Innova 3100 / 3100 IQ

  • Model / Serial
    SYSTEM ID: 65049331 850060732 2538483100 4082593100 7133933100 9284533100 82416060004 0002728403 01224VAS04  082416040025 082416100008 082416120017 082416230005 202782LABB  214324INNOVA2 27305ANGI1 303629CL4 303788CL2 318254CL 325428CATH1 361857CATH1 361980INNOVA2  478274CTH1 479441CV1  4959INV31 503561CL3 512901NI3100 563421CATHLAB8 573AMC3100  600123VA02  619482INNOVA1  650369SV3 704355RM2  706774HT8  717270INNOVA31  727942CATH  732776CATH6 770HMCCL2  787844INNOVACL 803256LAB2  808485INNOVA  814231C1 815226INN2  864512CL1  864512CL2  865481CCL2  951788INNOVA2 A51273120 BPINNOVA4 BPINNOVA5  BY4067VA02 BY4069VA01 FPG30528  HU1042VA01  IL1098VA01 NPV15952  PL1008VA02 RU1295VA03 RU1295VA04 RU1453VA01 RU1618VA01 RU1999VA01  RU2076VA02 RU2741VA03 RU2747VA01  RU3260VA01  RU3290VA01 RU3304VA01  RU3317VA01 RU3328VA01 UA4230VA01 XF0158 YV0044 YV0171  YV0175  YV0180  YV0700 Z001RX07
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, ARGENTINA, BELGIUM, BRAZIL, BULGARIA, CHINA, CROATIA, EGYPT, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LATVIA, LIBYA, MEXICO, NORWAY, POLAND, RUSSIA, SINGAPORE, SPAIN, SWEDEN, TAIWAN, TURKEY, UNITED KINGDOM, ROMANIA, ISRAEL, UKRAINE, YEMEN, BELARUS, and AUSTRALIA.
  • Product Description
    GE Healthcare, GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
  • Manufacturer
  • 1 Event

Manufacturer

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

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    3100IQ 01224VAS04 01367VAS02 2014183100 202782LABB 2035763100A 2036883100 205783BCL5 205877CCL1 205877CCL2 207879CL131 209334LINNOVA1 215576INNOVA1 2197573100 229312INOV1 251435ICV6 251633PROV 2538483100 262687CL3 270688I2100 2815993100 303629EP 308865GIN2 310825INNOVA31 314768SMCL1A 316689INNOVA31 316962WCVC1 316962WCVC2 317736CL1 318254CL 318798CL1 325428CATH1 325428CATH3 336832MCPV 337374INNOVA 352333CV3 352401CATH2 360456XCL3 360SJ3100 402559UCB 404686CRI3 405372S3100 405604D3100 405840OIC3100S 406447VAIN3 4082593100 412232A 412623A 412623C 413582C3100 414447CL1 415925INV1 417347FCV5 417885JCL7 417885JCL8 423495MCL6 423844CCL1 478274CTH1 503561CL3 504903INNOVA31 508941IN1 510797INV8 512901NI3100 541382CV3 541472CV1 541677MINNOVA1 541743CL6 561694IN1 570476INNOVA31 573458CL1 573AMC3100 58002VAS01 6012883100CV2 603421PCL 603580ECL1 606216CATH1 606216CATH2 606439INNOVA2 606678INNOVA 6067593100 609267IN3100 609597IN3100 609757IN3100 610526LAB1 610526LAB2 610595CL1 610645LAB6 610770INNOVA31 610954INNOVA1 610983INNOVA1 617754IN31 620225INNOVA31 6263973100 630312B31 631376EP 631968INNOVA2 631968INNOVA3 650369SV3 650938LY31 6619483100 662377CV2 662377CV4 678957INNOVA 704355PCL 704355RM2 704384CATH2 704384PHHCL 704384PHMCATH 704384PHMCATH 704878CL31 706481CCL 706774HT8 708WESTSUB3100 7133933100 717270INNOVA31 717544GECATH5 717782INNOVA31A 718245UNITY 718250CATH1 718270INNOVA1 718780CATH2 727521CATHOP 727725CATH2 732776CATH2 732776CATH6 760242CATH2 760323DRINNOVA 770991CL1 770HMCCL2 772LWCL2 785354S3100 803255CL1 803256LAB2 803776CL1 804285CATH1 8053703100 808485INNOVA 812237THR31 815226OSFLAB1 815344CARDIAC3 815756KCHSPEC 8184093100 8185023100 8189813100XX 843674INNOVA2 843692CATH2 847362CONCATH4 8508573100 850862IN3100 863687CL31 864255SFCL3 864512CL1 864512CL2 864512CL4 865693CCL1 903HC3100 903UT3100 910343NHIN4 912486CATH1 918333JPIN2 919731WMINOV 919784REP1 9202623100 9284533100 9287883100 931459CV1 BG4549VA02 BY4067VA02 DPM32143 DR3100 FHORLCL7 FPG30528 HC4348XR01 KMC3100 MARTINSVILLE310 MCDCATH2 MCDCATH4 NO1000VA03 NPV15952 PER08306 PL1491VA01 PL1553VA01 PL1650VA02 PL1688VA01 RU1013VA02 RU1295VA02 RU1295VA03 RU1295VA04 RU1346VA01 RU1453VA01 RU1475VA01 RU1550VA02 RU1618VA01 RU2076VA02 RU2442VA01 RU2558VA01 RU2741VA03 RU2747VA01 RU2886VA01 RU3053VA01 RU3136VA01 RU3230VA01 RU3230VA02 RU3253VA01 RU3285VA01 RU3317VA01 RU3328VA01 RU3331VA01
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK ,OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI and the countries of ANGOLA, BELARUS, BULGARIA, CANADA, EGYPT, FRANCE, GERMANY, HUNGARY, IRELAND, MEXICO, ITALY, NIGERIA, NORWAY, POLAND, PORTUGAL, RUSSIAN FEDERATION, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, TUNISIA, TURKEY, and the UNITED KINGDOM
  • Product Description
    Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) || The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications.
  • Manufacturer
  • Model / Serial
    2652143 2014183100 201541LAB2 201996LAB1 2035763100 2035763100A 2036883100 205783BCL5 205877CCL1 205877CCL2 207351YCL1 207662CL4 207879CL131 208227CATH2 209334LINNOVA1 214324INNOVA2 214590PH3100 215335INNOVA1 215576INNOVA1 219326IN31 2197573100 219877IN2 219877IN31 228818VASC 239436CATH3 239513CRLAB1 239939CLA 251435ICV6 251633PROV 253968INNOVA 254742KDCL1 262687CL3 270688INN 281420LAB1 281420LAB23100 281440CL3 3027443100 303425CL4 303629CL4 303629EP 303788CL2 305364P3100 308865GIN2 309691P3100 310319SM3100 310423INNOVA1 310825INNOVA31 312STMNAZ3100 313593IC1 313593IC2 314525STACL2 314768SMCL1A 314768SMCL3 316268INNOVAA 316651INNOVA31 316962WCVC1 316962WCVC2 318448INNOVA2 318449INNOVA2 318798CL1 325428CATH1 325428CATH3 334418CL 336832MCPV 337374INNOVA 352333CATH1 352333CATH2 360456XCL3 361857CATH1 361980INNOVA2 402559UCB 404686CRI3 405272SCL2 405372S3100 405604D3100 405610NW3100 405840OIC3100 406447VAIN3 406543IN3 409899LAB3 4103323100 4103623100 412437INNOVA 413447CATH 413540IN1 413582C3100 414447CL1 414647CL1 414649CL3 414649CL4 414805INNOVA1 415925INV1 417269SCLD 417347FCV5 417885JCL7 417885JCL8 423495MCL6 423844CCL1 478274CTH1 479441SP3100 480728LAB2 480821IN2 502587LAB1 502587LAB4 502852INNOVA 5033703100 5034353100 507385INN3100 508856IN2 508941IN1 509946CATH2 510797INV8 512901NI3100 516562INNOVA8 516562INNOVA9 516632INNOVA2 516663INNOVA1A 516663INNOVA2 518525LAB1 530244XC106 540953INNOVA 541382CV3 541677MINNOVA1 541743CL6 541MWHINNOVA 561266IN31 561548CL4 570476INNOVA31 573458CL1 573632CRC2 573815BCR1 573882UMC1 580548B3100 6012883100CV2 601553CL3 601883CL1 602239LAB4 602239LAB6 602266LAB2 603421PCL 603580ECL1 608524NOVA 609757IN3100 610447CL1 610526LAB1 610526LAB2 610595CL1 6106483100 610770INNOVA31 610891CL1 610954INNOVA1 610983INNOVA1 615338CV2 615769SKYCV2 616392INNOVA 617732IN9 617789IN1 618241GSI3100 619340VA8 619457INNOVA5 619482INNOVA1 619541INNOVA31 619552INNOVA1 620225INNOVA31 630312B31 630856H31 631376EP 631968INNOVA2 631968INNOVA3 650369SV3 65049331 6619483100 662377CV2 662377CV4 671GMHAINVA 678957INNOVA 7018573100 7022333100 702616INNOVA 7028533100 7028803100A 704355RM2 704384CATH2 704384PHMCATH 704878CL31 706481CCL 706774CCL4 706774CCL5 7083333100 708WESTSUB3100 713359INC 713776M3100 713794LAB7 713794LAB9 713948INA 714843INNOVA 714966INNOVA 717217INN31 717782INNOVA31 717782INNOVA31A 717782INNOVA31B 718245UNITY 718250CATH1 718270INNOVA1 718283INNOVA3 718470INNOVA2 718780CATH2 724773C1 727725CATH2 7278253100 731422CV1 732294INOV 732776CATH6 760242CATH1 760242CATH2 760323DRINNOVA 765453INNOVA1 770991CL1 770991CL3 772LWCL1 773792CL3100 773NORWG3100 775982CATH2 781340IN2 785354S3100 8014793100 8019643100 803255CL1 803256PCL1 803329CL31 804285CATH1 8053703100 808547QCV2A 812238LIB1 812283IN31 812450CATH1 812450EP1 812450EP1 812482INNOVA 812858GWLAB1 812858GWLAB2 814676C1 815226INN2 815344CARDIAC3 815599FHN3100 8157413100 815756KCHSPEC 816478MC1 816861KCVAI1 816943STJIC1 816969LSCATH 816985NKCI 817433HSW3100 8184093100 8185023100 8189813100 843797TCL2 845365V19 847362CONCATH4 850469BCV1 850678IN3100 850747BR3100 850747GC3100 850862IN3100 856596IN3100 8613100 863687CL31 864255SFCL3 865481CCL2 865512CL3 865693CCL1 901516R3 903UT3100 904202CATH3 904276CTH1 904276CTH1 907562CATH1 908522LAB1 909464IN3 909788INNOVA1 909825VAINNOVA 910343NHIN4 912486CATH1 913345MI1 916781INNOVA1 918333JPIN1 918333JPIN2 918494IN31A 919731WMINOV 919784REP1 9202623100 925779INNOVA408 928779INNOVA1 931459CV1 936266CL1 940626DCH3100 941798CLAB2 951788INNOVA2 951788INNOVA3 951788INNOVA3 952993INNOVA5 954987CCL9 956389INN31 956698INN31 956994INN1 956994INN2 970350CL1 970945CL1 9734293100 973877LAB4 973971LAB3 BPINNOVA1 BPINNOVA2 BPINNOVA3R DR3100 ECXV1406B FHORLCL1 FHORLCL7 LVINOV4 MARTINSVILLE310 MCDCATH2 2575081 2601648 2610213 2625271 2638199 2652070 2656470 2661770 2680614 2681424 2682930 2686429 2698717 2699058 2713223 2713498 2713501 2713606 2716215 2724811 2725165 2727031 2728632 2729012 2729039 2730996 2731216 2731616 2732637 2739644 2741814 2742714 2745812 2745843 2745917 2749863 2750261 2751926 2752431 2753571 2753701 2754912 2754940 2754953 2754989 2755128 443481LCV 504447INNOVA2 580421V3100 609267IN3100 609597IN3100 610645LAB6 732776CATH2, and 909CH3100
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including states of CA, FL, NY, AK, AL, AR, AZ, PA, FL ,CO, SC, CT, IA, DC, DE, GA, HI, IL , IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NJ, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and GUAM.
  • Product Description
    Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane || Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology.
  • Manufacturer
  • Model / Serial
    82416120006, 4103323100, 82416120005, and 214324INNOVA2
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA including states of MD, TX, and VA and country of China.
  • Product Description
    GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) || Indicated for use in diagnostic and interventional angiographic procedures of human anatomy. Intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. Not intended for mammography applications.
  • Manufacturer