Devices

GE LightSpeed VCT

  • 모델명 / 제조번호(시리얼번호)
    Model 5212920-300, serial numbers: 00000021775YC2. 00000408285CN5. 00000409136CN9. 00000412029CN1. 00000412391CN5. 00000414803CN7. 00000415599CN0. 00000416813CN4. 00000417885CN1.   Model 5212920-310, serial numbers: 00000416740CN9. 00000417311CN8. 00000417519CN6. 00000417884CN4. 00000417886CN9. 00000417916CN4. 00000417917CN2. 00000417918CN0. 00000417919CN8. 00000417925CN5. 00000417926CN3. 00000417989CN1. 00000417990CN9. 00000418000CN6. 00000418055CN0. 00000418056CN8. 00000418057CN6. 00000418058CN4. 00000418059CN2. 00000418060CN0. 00000418062CN6. 00000418063CN4. 00000418064CN2. 00000418065CN9. 00000418126CN9. 00000418141CN8. 00000418142CN6. 00000418179CN8. 00000418218CN4. 00000418219CN2. 00000418220CN0. 00000418221CN8. 00000418222CN6. 00000418246CN5. 00000418260CN6. 00000418261CN4. 00000418266CN3. 00000418272CN1. 00000418293CN7. 00000418296CN0. 00000418337CN2. 00000418355CN4. 00000418365CN3. 00000418400CN8. 00000418404CN0. 00000418467CN7. 00000418541CN9. 00000418542CN7. 00000418581CN5. 00000418586CN4. 00000418604CN5. 00000418706CN8. 00000418717CN5. 00000418789CN4. 00000418790CN2. 00000418793CN6.   Model 5311595-10, serial numbers: 00000031546CO5. 00000031835CO2. 00000031838CO6.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    GE LightSpeed VCT Scanner System, models 5212920-300, 5212920-310, 5311595-10. 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. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 USA. || 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
    GE Healthcare, LLC
  • 1 Event

제조사

GE Healthcare, LLC
  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall GE LightSpeed VCT System
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Puerto Rico, Albania, Argentina, Austria, Australia, Belarus, Belgium, Bulgaria, Brazil, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Great Britain, Greece, Guam, Hong Kong, Honduras, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia , Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Reunion Island, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain , Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Venezuela, Vietnam, and Yugoslavia.
  • 제품 설명
    The LightSpeed VCT System is intended for head and whole body X-ray Computed Tomography applications.
  • Manufacturer
    GE Healthcare