GE BrightSpeed CT

  • Model / Serial
    Model 2377708-560, serial numbers: 00000018952YC2. 00000018953YC0. 00000018954YC8. 00000019505YC7. 00000019506YC5. 00000019507YC3. 00000019508YC1. 00000019509YC9. 00000019663YC4. 00000019664YC2. 00000019665YC9. 00000019772YC3. 00000019773YC1. 00000019898YC6. 00000019899YC4. 00000020095YC6. 00000020147YC5. 00000020277YC0. 00000020278YC8. 00000020708YC4. 00000020709YC2. 00000020710YC0. 00000020835YC5. 00000020888YC4. 00000020936YC1. 00000020937YC9. 00000021104YC5. 00000021105YC2. 00000021106YC0. 00000021286YC0. 00000021287YC8. 00000021288YC6. 00000021289YC4. 00000021485YC8. 00000021486YC6. 00000021487YC4. 00000021488YC2. 00000021638YC2. 00000021639YC0. 00000021640YC8. 00000021850YC3. 00000021851YC1. 00000021966YC7. 00000021967YC5. 00000021975YC8. 00000021976YC6. 00000022244YC8. 00000022245YC5. 00000023063YC1. 00000023602YC6. 00000023981YC4. 00000024234YC7. 00000024374YC1. 00000025318YC7. 00000208246HM9. 00000210066HM7. 00000210067HM5. 00000210068HM3. 00000210069HM1. 00000210070HM9. 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00000219704HM4. 00000220155HM6. 00000220156HM4. 00000220157HM2. 00000220158HM0. 00000220159HM8. 00000220512HM8. 00000220513HM6. 00000220514HM4. 00000220515HM1. 00000221055HM7. 00000221056HM5. 00000221057HM3. 00000221058HM1. 00000221059HM9. 00000221060HM7. 00000221681HM0. 00000221710HM7. 00000221711HM5. 00000221712HM3. 00000221713HM1. 00000221714HM9. 00000222284HM2. 00000222285HM9. 00000222286HM7. 00000222287HM5. 00000222288HM3. 00000222289HM1. 00000222784HM1. 00000222785HM8. 00000222786HM6. 00000222787HM4. 00000222788HM2. 00000222789HM0. 00000222790HM8. 00000222791HM6. 00000223455HM7. 00000223456HM5. 00000223534HM9. 00000223535HM6. 00000223536HM4. 00000223537HM2. 00000223538HM0. 00000223539HM8. 00000223540HM6. 00000223541HM4. 00000223542HM2. 00000223543HM0. 00000223900HM2. 00000223901HM0. 00000223902HM8. 00000223903HM6. 00000223904HM4. 00000224529HM8. 00000224530HM6. 00000224531HM4. 00000224541HM3. 00000224967HM0. 00000225116HM3. 00000225117HM1. 00000225118HM9. 00000225276HM5. 00000225277HM3. 00000225278HM1. 00000225279HM9. 00000225280HM7. 00000225839HM0. 00000225840HM8. 00000225841HM6. 00000225842HM4. 00000226232HM7. 00000226233HM5. 00000226234HM3. 00000226235HM0. 00000226236HM8. 00000226840HM7. 00000226841HM5. 00000226842HM3. 00000226843HM1. 00000227337HM3. 00000227338HM1. 00000227339HM9. 00000227340HM7. 00000227934HM7. 00000227935HM4. 00000227936HM2. 00000227937HM0. 00000227938HM8. 00000230075HM4. 00000230076HM2. 00000230077HM0. 00000231039HM9. 00000231040HM7. 00000231049HM8. 00000231498HM7. 00000231499HM5. 00000231500HM0. 00000231501HM8. 00000231654HM5. 00000234977HM7. 00000235478HM5. 00000236624HM3. 00000236689HM6. 00000236914HM8. 00000237109HM4. 00000237608HM5. 00000237609HM3. 00000237610HM1. 00000237611HM9. 00000239250HM4. 00000239251HM2. 00000239252HM0. 00000241506HM5. 00000241620HM4. 00000242448HM9. 00000242449HM7. 00000243034HM6. 00000243945HM3. 00000244390HM1. 00000244391HM9. 00000244392HM7. 00000245923HM8. 00000245924HM6.  Model 5377708-540, serial numbers: 00000017325YC2. 00000017326YC0. 00000017327YC8. 00000017470YC6. 00000017471YC4. 00000017507YC5. 00000017508YC3. 00000017509YC1. 00000017510YC9. 00000017511YC7. 00000017512YC5. 00000017621YC4. 00000017665YC1. 00000017666YC9. 00000017821YC0. 00000017822YC8. 00000017823YC6. 00000017824YC4. 00000017825YC1. 00000017826YC9. 00000017827YC7. 00000018175YC0. 00000018181YC8. 00000018182YC6. 00000018183YC4. 00000018217YC0. 00000018218YC8. 00000018298YC0. 00000018299YC8. 00000018300YC4. 00000018403YC6. 00000018404YC4. 00000018511YC6. 00000018512YC4. 00000018513YC2. 00000018601YC5. 00000018602YC3. 00000018695YC7. 00000018696YC5. 00000018697YC3. 00000018698YC1. 00000018784YC9. 00000018785YC6. 00000018786YC4. 00000018900YC1. 00000018901YC9. 00000018902YC7. 00000018903YC5. 00000018904YC3. 00000018905YC0. 00000018957YC1. 00000019048YC8. 00000019049YC6. 00000019126YC2. 00000019127YC0. 00000019255YC9. 00000019256YC7. 00000019257YC5. 00000019401YC9. 00000019402YC7. 00000019403YC5. 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00000202626HM8. 00000202627HM6. 00000202628HM4. 00000203596HM2. 00000203600HM2. 00000203601HM0. 00000203602HM8. 00000203603HM6. 00000204144HM0. 00000204145HM7. 00000204163HM0. 00000204164HM8. 00000204197HM8. 00000204198HM6. 00000204199HM4. 00000205488HM0. 00000205489HM8. 00000205496HM3. 00000205497HM1. 00000205498HM9. 00000205936HM8. 00000205937HM6. 00000205938HM4. 00000205939HM2. 00000205962HM4. 00000205963HM2. 00000205964HM0. 00000205965HM7. 00000205966HM5. 00000205967HM3. 00000205998HM8. 00000205999HM6. 00000206848HM4. 00000206849HM2. 00000207034HM0. 00000207035HM7. 00000207361HM7. 00000207362HM5. 00000207741HM0. 00000207742HM8. 00000208226HM1. 00000208227HM9. 00000208228HM7. 00000208229HM5. 00000208230HM3. 00000208253HM5. 00000208691HM6. 00000208692HM4. 00000208701HM3. 00000208702HM1. 00000208703HM9. 00000208704HM7. 00000209561HM0. 00000209578HM4. 00000209579HM2. 00000209611HM3. 00000209612HM1. 00000210016HM2. 00000210017HM0. 00000214731HM2. 00000214734HM6.  Model 5377708-560, serial numbers: 00000019027YC2. 00000019577YC6. 00000019578YC4. 00000019579YC2. 00000019651YC9. 00000019652YC7. 00000019808YC5. 00000019809YC3. 00000019910YC9. 00000019911YC7. 00000020098YC0. 00000020152YC5. 00000020153YC3. 00000020283YC8. 00000020284YC6. 00000020456YC0. 00000020457YC8. 00000020458YC6. 00000020471YC9. 00000020522YC9. 00000020523YC7. 00000020711YC8. 00000020712YC6. 00000020713YC4. 00000020757YC1. 00000020758YC9. 00000020837YC1. 00000020942YC9. 00000020943YC7. 00000021158YC1. 00000021159YC9. 00000021160YC7. 00000021264YC7. 00000021270YC4. 00000021271YC2. 00000021272YC0. 00000021666YC3. 00000021667YC1. 00000021668YC9. 00000021669YC7. 00000021670YC5. 00000021767YC9. 00000021768YC7. 00000021769YC5. 00000021880YC0. 00000021881YC8. 00000022160YC6. 00000022161YC4. 00000022162YC2. 00000022163YC0. 00000022259YC6. 00000022260YC4. 00000022261YC2. 00000022352YC9. 00000022353YC7. 00000022457YC6. 00000022458YC4. 00000022459YC2. 00000022460YC0. 00000022705YC8. 00000022706YC6. 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  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: MI, NM, OH, TX, and Puerto Rico and countries including: Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hungary, India, Indonesia, Ireland, Islamic Republic of Iran, Israel, Italy, Jamaica, Japan, Kenya, Lebanon, Malaysia, Mauritania, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Pakistan, Paraguay, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Togo, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Viet Nam.
  • Product Description
    GE BrightSpeed Excel/Edge/Elite Select / Elite CT Scanner System, models 2377708-560, 5377708-540, 5377708-560. Composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. || Is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions.
  • Manufacturer
  • 1 Event

Manufacturer

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