Device Recall GE PET/CT System

  • Model / Serial
    Mfg Lot or Serial # System ID 00000006841PT1 PET368725CN8 00000004411PT5 4512-1 00000004411PT5 4512-1 00000006841PT1 PET368725CN8 00000005376PT9 PET357769CN9 00000005670PT5 082426140014 00000006610PT0 082445020003 00000006610PT0 082445020003 00000006610PT0 082445020003 00000006119PT2 082445030003 00000005815PT6 082445050003 00000006146PT5 082445090002 00000005808PT1 082445100008 00000006177PT0 082445100009 00000006175PT4 082445130004 00000005670PT5 082426140014 00000005808PT1 082445100008 00000006500PT3 082445160007 00000006242PT2 082445190002 00000006200PT0 082445250002 00000005251PT4 H4858964 00000005121PT9 M4143813 00000005352PT0 M4144860 00000005323PT1 X105967801 00000006194PT5 HU1167PT01 00000006762PT9 0004168403 00000006762PT9 0004168403 00000005809PT9 IE1005PT01 00000004588PT0 IL1062NM18 00000006120PT0 A5107746 UNK51012720002 A5107746 UNK51012720001 A5215931 00000006003PT8 A5333025 00000004619PT3 A99263301 00000006292PT7 YD0024 00000006293PT5 YD0025 00000006039PT2 YE0001 00000006273PT7 YE0002 00000006272PT9 YE0003 00000006345PT3 YE0004 00000006346PT1 YE0005 00000006808PT0 YE0006 00000006488PT1 YE0007 00000006403PT0 YE0008 00000006368PT5 YE0011 00000006274PT5 YE0077 00000005920PT4 YE0101 00000006141PT6 YE0102 00000006076PT4 YE0103 00000006404PT8 YE0104 00000006496PT4 YE0105 00000006405PT5 YE0106 00000006453PT5 YE0107 00000006636PT5 YE0108 00000006331PT3 YE0110 00000006347PT9 YE0111 00000006454PT3 YE0112 00000006115PT0 YE0201 00000006407PT1 YE0202 00000006611PT8 YE0203 00000006245PT5 YE0205 00000006810PT6 YE0210 00000006843PT7 YE0211 00000005813PT1 YE0214 00000006367PT7 YE0109 00000006304PT0 YE0204 00000005813PT1 YE0214 00000004967PT6 0850450042 00000004967PT6 0850450042 00000004967PT6 0850450042 00000004967PT6 0850450042 00000004463PT6 0850450055 00000005495PT7 0850450056X1 00000005342PT1 0850450057 00000005342PT1 0850450057 00000005878PT4 0850450058 00000006176PT2 0850450059 00000006176PT2 0850450059 00000005785PT1 0834450001 00000005785PT1 0834450001 00000005719PT0 2535997DST 00000005719PT0 2535997DST 00000006486PT5 2546945DST 00000006148PT1 FE816135 UNK51012720004 FE816135 00000004732PT4 FEG81300 00000006302PT4 NP739714 UNK51012720000 Not Available 00000006201PT8 C001PE03 00000006201PT8 C001PE03 00000006294PT3 259130PE01 00000006294PT3 259130PE01 00000005184PT7 0853450020 00000004676PT3 0853450021 00000005784PT4 0853450023 00000005880PT0 0853450026 00000006244PT8 0853450038 00000006244PT8 0853450038 00000006501PT1 0853450062 00000004624PT3 06008PET01 00000005169PT8 01293DST01 UNK51012720003 10495DST01 00000005892PT5 561883DST 00000006457PT6 388559737PETMET
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Product Description
    LightSpeed QX/I (4-slice MDAS) || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    Mfg Lot or Serial # System ID 00001035638YM4 082421010179 00000001887YC9 082421010327 00001035639YM2 082421020108 00001035636YM8 082421020109 00001031633YM9 082421030253 00001031634YM7 082421030254 00000003852YC1 082421030266 00001031640YM4 082421040157 00001035634YM3 082421060051 00000001885YC3 082421060054 00001035641YM8 082421080078 00001031632YM1 082421090164 00001035640YM0 082421090168 00001031639YM6 082421100318 00001031638YM8 082421120200 00000003853YC9 082421140187 00001031637YM0 082421150068 00000001883YC8 082421200244 00000001888YC7 082421270069 00001035633YM5 082421310091 00000001891YC1 082421040171 00000001892YC9 082421040177 00000001889YC5 082421090174 00000001890YC3 082421090175 00000001886YC1 082421310106
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Product Description
    LightSpeed Ultra (8-slice MDAS), 5120327-3 || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer
  • Model / Serial
    Mfg Lot or Serial # System ID 00000002631PT0 4860AW442 00000002631PT0 4860AW442 00000318118CN7 0910213115 00000002808PT4 0910453003P 00000318118CN7 0910213115 00000318118CN7 0910213115 00000980093YM9 0910212119 00000002247PT5 090016PT01 00000326200CN3 110012CT01 00000311426CN1 030018CT01 00000002103PT0 2728449 00000003306PT8 2757760XXX 00000003306PT8 2757760XXX 00000003310PT0 47867 00000002103PT0 2728449 00000002103PT0 2728449 00000339630CN6 BG4029CT01 00000298328CN6 204787LS1 00000298660CN2 204787LSPD2 00000307018CN2 416249LS16 00000309304CN4 519744LS16 00000309524CN7 819379LS 00000310680CN4 418862LS 00000312264CN5 450656LS 00000316257CN5 613761LS16 00000317195CN6 604988LS16 00000318444CN7 514499LS 00000318927CN1 514468BLS 00000319310CN9 519421LS16 00000324459CN7 450466LS 00000328940CN2 450654LS 00000329994CN8 819561LS 00000332076CN9 506648LS16 00000335314CN1 514934CLS16 00000341799CN5 416284LS16 00000341801CN9 416744LS16 00000341802CN7 905883LS16 00000347191CN9 450778LS 00000348810CN3 416924DST 00000349405CN1 514934BDST 00000994091YM7 418549LS 00000334561CN8 26329CT4X 00000002642PT7 082445310001 00000002660PT9 082445310003 00000340577CN6 082421120176 00000340630CN3 082421140148 00000989604YM4 082421030247 00000989603YM6 082421040128 00000989606YM9 082421080068 00000989606YM9 082421080068 00000989602YM8 082421100277 00000989607YM7 082421210116 00000352887CN4 USONCDST16 00000346880CN8 2532905LIG16 00000295643CN1 FI1017CT02 00000334897CN6 A9190135 00000001843PT2 B4155412 00000334897CN6 A9190135 00000002494PT3 GOLD010013 00000341585CN8 GOLD010316 00000336468CN4 M4143946 00000002494PT3 GOLD010013 00000339849CN2 M4215541 00000339849CN2 M4215541 00000336833CN9 M4434860 00000341585CN8 GOLD010316 00000341585CN8 GOLD010316 00000341585CN8 GOLD010316 00000001843PT2 B4155412 00000293499CN0 M5481223 00000302751CN3 M4516011 00000309305CN1 M4491923 00000310268CN8 M4191025 00000313650CN4 C6010809 00000326112CN0 M1279722 00000329304CN0 X993729001 00000980112YM7 M4490502 00000317863CN9 GOLD002055 00000297427CN7 GOLD001604 00000031399CN5 CC0618CT03 00000313999CN5 CC0618CT03 00000988382YM8 HC4912CT02 00000330530CN7 0828210047 00000339850CN0 IS1001CT01 00000339850CN0 IS1001CT01 00000002861PT3 0002740730 00000002861PT3 0002740730 00000002861PT3 0002740730 00000334896CN8 0835210046X 00000002164PT2 IL1020NM18 00000980121YM8 IL1082CT02 00000002389PT5 A5128738 UNK22863270001 A5148558 00000317806CN8 A5152959 00000334895CN0 A5177358 00000325622CN9 A5269709 00000334875CN2 A5696306 00000003599PT8 A5645905 00000339627CN2 B5119111 00000339627CN2 B5119111 00000002207PT9 C5126802 00000003008PT0 YH0011 00000003080PT9 YH0012 00000002826PT6 YH0015 00000002969PT4 YH0016 00000003247PT4 YH0017 00000003662PT4 YH0019 00000003973PT5 YH0025 00000003972PT7 YH0026 00000004113PT7 YH0028 00000003102PT1 YN1033 00000327052CN7 QV0023 00000989605YM1 XF0149 00000001950PT5 YH0008 00000002711PT0 YH0010 00000002664PT1 YH0014 00000003663PT2 YH0020 00000003733PT3 YH0020 00000003733PT3 YH0020 00000003734PT1 YH0022 00000003732PT5 YH0023 00000004107PT9 YH0033 00000292947CN9 QW2004 00000294147CN4 QZ0009 00000294768CN7 QW2005 00000298361CN7 QX0014 00000298654CN5 QW2009 00000298785CN7 QZ0008 00000301211CN9 QZ0006 00000303436CN0 QY0017 00000307949CN8 QW3031 00000313364CN2 QW3041 00000988392YM7 QW3080 00000941023YM4 QW3078 00000941023YM4 QW3078 00000953832YM3 QT3035 00000980119YM2 QZ0020 00000345972CN4 0850210561 00000339481CN4 LV4000CT01 00000002663PT3 LB1077MN01 00000318890CN1 LT4000CT01 00000328801CN6 LT4001CT01 00000345987CN2 030013CT04 00000324061CN1 NO1016CT04 00000324061CN1 NO1016CT04 00000002442PT2 0843450002 00000338649CN7 PPR05009 00000002051PT1 MPX33107 00000339848CN4 O005CT06 00000315961CN3 Z001CT02 00000327581CN5 Z001CT02 00000345782CN7 120928CT01 00000314376CN5 260010CT13 00000002163PT4 529150PE01 00000315054CN7 547090CT05 00000345782CN7 120928CT01 00000314530CN7 725030CT01 00000341587CN4 794130CT02 00000002163PT4 529150PE01 00000315054CN7 547090CT05 00000296274CN4 501030CT02 00000323859CN9 259130CT02 00000346701CN6 900010PE08 00000003006PT4 0853450002 00000003004PT9 0853450003 00000002699PT7 0853450004 00000309505CN6 00243CTS06 00000309505CN6 00243CTS06 00000309505CN6 00243CTS06 00000003709PT3 10094PTM62 UNK22863270000 10094PTM62 00000003709PT3 10094PTM62 00000312815CN4 10458CTS01 00000318595CN6 00537CTS01 00000317863CN9 GOLD002055 00000341584CN1 315329CT16 00000341584CN1 315329CT16 303586CN2 SHICT24 311423CN8 559686DGCT1 309307CN7 SHICT18 318593CN1 MHOPSPLS16 297597CN7 MHOPFWCT1 311813CN0 281283MCLCT 311057CN4 713MHNWLS16 298358CN3 912486GECT 00000334468CN6 361PRMPKDL 304685CN1 210572TOLS16 329303CN2 MPXLS16 00000341884CN5 SHICT66 342627 509575YM16CT 00000277800CN9 415723SCT3 00000284984CN2 630352DST 00000288654CN7 703385LS16 00000292531CN1 423272CT 00000293011CN3 CT81441 00000293033CN7 CDISCT1 00000293034CN5 419584CT 00000293036CN0 352597PET 00000293037CN8 631475LS16 00000294043CN5 919BCLS16 00000294051CN8 312266L16 00000294344CN7 504873TL16 00000294345CN4 SMGCT15 00000294503CN8 770718OCT1 00000294504CN6 949760CT2 00000294506CN1 315464CT16 00000294765CN3 251368ACT 00000294766CN1 402481BWCT1 00000294857CN8 512AERNCT 00000294858CN6 RADNETCT443 00000294996CN4 404616QXI 00000295003CN8 561989CT4 00000295004CN6 509946LSCT 00000295005CN3 785452SCT 00000295006CN1 404732QXI 00000295116CN8 302738LS16 00000295119CN2 608263CT1 00000295120CN0 225769RGLS1 00000295121CN8 469525DLS 00000295122CN6 713932MCT3 00000295123CN4 814238LS1 00000295124CN2 502560ULT3 00000295125CN9 662841CT1 00000295410CN5 919731CT16 00000295416CN2 314768SMCT 00000295418CN8 903ADVCT16 00000295641CN5 920568CT16 00000295642CN3 805988GICT 00000295882CN5 727372LS16 00000295883CN3 704487LS16 00000295884CN1 916RICCT16 00000296271CN0 414541QXI4 00000296272CN8 518828CT 00000296275CN1 214705FCER 00000296277CN7 225761CT1 00000296279CN3 949631CT1 00000296280CN1 805SVCT1 00000297008CN5 415929KCT 00000297382CN4 206232CT1 00000297422CN8 ALLIANCECT66 00000297424CN4 317962LSP1 00000297425CN1 770677DST 00000297426CN9 412777LS16 00000297461CN6 903757QXI16 00000297464CN0 864716CTU1 00000297601CN7 925KWCCT2 00000297899CN7 603650LS16 00000297901CN1 203852CT16 00000297903CN7 315332CT16 00000297993CN8 702616CT 00000297994CN6 845783ORA01 00000297996CN1 281FCDPCT 00000298320CN3 909558CT4 00000298326CN0 262785CT3 00000298345CN0 734240CT16 00000298360CN9 210292LSA 00000298362CN5 404875QXI 00000298363CN3 281OBMCCT 00000298367CN4 662841CT2 00000298656CN0 321434HRCT2 00000298657CN8 214879L16A 00000298658CN6 214820NPLS16 00000298786CN5 817377LS16 00000298789CN9 RADNETPT611 00000298790CN7 ALLIANCECT67 00000298791CN5 317274ROCLS 00000298793CN1 847LS16CT1 00000299039CN8 936271CT1 00000299040CN6 315464UBJCT 00000299041CN4 304526LS16 00000299078CN6 813932LS16 00000299234CN5 RADNETCT1500 00000299311CN1 910215MR16 00000299312CN9 208354CT 00000299313CN7 SMGCT36 00000299484CN6 480820CT16 00000299485CN3 913676SLS16 00000299487CN9 586493H16 00000299763CN3 208467CTLS 00000299764CN1 FHOMPOPC1 00000299765CN8 703578LS16 00000299767CN4 850434BCT1 00000299768CN2 409899LS03 00000299933CN2 SHICT251 00000299950CN6 858939CT1 00000299954CN8 RADNETCT1447 00000300246CN6 704783LS16 00000300247CN4 515263CT1 00000300371CN2 573635SMCT2 00000300373CN8 702877CT1 00000300374CN6 503674CT 00000300490CN0 ALLIANCECT136 00000300854CN7 605882CT 00000300855CN4 702228CT 00000301082CN4 718334LS01 00000301083CN2 903594OLS 00000301084CN0 914737CTLS 00000301086CN5 312423LS16 00000302752CN1 718334LS02 00000303081CN6 913588KQXI 00000303515CN1 662841CT3 00000303581CN3 513867CT 00000303584CN7 301759CT16 00000303585CN4 651254CT3 00000303588CN8 973926LS16 00000303590CN4 404321QXI 00000304110CN0 303427LS1 00000304113CN4 276666CT 00000304156CN3 87FERMANCT 00000304157CN1 602277CT16 00000304159CN7 805988PET1 00000304684CN4 714633CTM 00000304687CN7 970244AMPCT 00000304688CN5 708342LS16 00000305240CN4 SHICT60 00000305525CN8 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ALLIANCECT148 00000002993PT4 38852995PETMET
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Product Description
    Discovery LS, 2286327 || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer
  • Model / Serial
    Mfg Lot or Serial # System ID 00000312256CN1 4860LS16GS 00000312256CN1 4860LS16GS 00000312256CN1 4860LS16GS 00000294153CN2 0910212097 00000309306CN9 0910212101 00000309960CN3 0910212104 00000309960CN3 0910212104 00000311052CN5 0910212105 00000321402CN0 0910212106 00000321402CN0 0910212106 00000337340CN4 0910212115 00000337340CN4 0910212115 00000337340CN4 0910212115 00000297003CN6 0910213064 00000313645CN4 0910213070 00000301209CN3 0910215018 00000313097CN8 0910216036 00000337344CN6 0910216041 00000297460CN8 AH1410CT06 00000325191CN5 AH5362CT02 00000310728CN1 110037CT01 00000310728CN1 110037CT01 00000299935CN7 190020CT03 00000311058CN2 190052CT06 00000297386CN5 190059CT04 00000311058CN2 190052CT06 00000311426CN1 030018CT01 00000297596CN9 BA4142CT01 00000297596CN9 BA4142CT01 00000297596CN9 BA4142CT01 00000327271CN3 10026 00000346702CN4 1350651 00000310682CN0 2850998 00000310682CN0 2850998 00000327815CN7 CT327815CN7 00000332075CN1 BG4037CT01 UNK23399850000 BG4037CT01 00000316663CN4 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  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Product Description
    Discovery ST, , 2339985 || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer
  • Model / Serial
    Mfg Lot or Serial # System ID 00000350495CN8 A5333025 00001001853YM9 AL4004CT01 00000953838YM0 AL4023CT01 00001001879YM4 0002876927 00000357924CN0 1577LS16 00001001879YM4 0002876927 00001001879YM4 0002876927 00001001879YM4 0002876927 00001010424YM8 0910212127 00001010461YM0 0910212129 00001010461YM0 0910212129 00001010471YM9 0910213084 00000980093YM9 0910212119 00000980093YM9 0910212119 00000994084YM2 0910212123X 00000984698YM1 0910213080 00001010387YM7 0910215023 00001010475YM0 0910215025 00001001897YM6 AH5703CT01 00000980120YM0 AH4001PE01 00000988410YM7 110002CT02 00000953828YM1 110017CT01 00000980106YM9 110040CT03 00000953853YM9 110059CT01 00000988410YM7 110002CT02 00000980111YM9 030355CT03 00000980111YM9 030355CT03 00001002103YM8 2858149 00000383739CN0 CT383739CN0 00000980108YM5 BF1012CT01 00000980108YM5 BF1012CT01 00000980108YM5 BF1012CT01 00000988391YM9 CT988391YM9 00000988391YM9 CT988391YM9 00000988391YM9 CT988391YM9 00001002107YM9 082421120191 00000364134CN7 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  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Product Description
    LightSpeed 16 (MDAS only || , , 2339985 || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer
  • Model / Serial
    Mfg Lot or Serial # System ID 00000002493PT5 0850450029
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Product Description
    LightSpeed Plus (4-slice MDAS || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer