GE OEC Medical Systems, Inc

13 devices in the database

  • Model / Serial
    GE OEC Brivo 865 Plus Serial Numbers:  B4S13011 B4S13012 B4S13016 B4S13018 B4S13020 B4S13029 B4S13031 B4S13035 B4S13038 B4S13043 B4S13054 B4S13056 B4S13059- B4S13061 B4S14002- B4S14004 B4S14007 B4S14015 B4S14016 B4S14022 B4S14022 B4S1403 3 B4S1403 4
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product || Used for general surgical applications and musculoskeletal procedures to visualize.
  • Model / Serial
    GE OEC Brivo 715 Prime Serial Numbers:  B2S1301 6 B2S1301 8 B2S1302 1 B2S13022 B2S13025 B2S13039 B2S13060 B2S13063 B2S13065 B2S14001 B2S14007 B2S14022 B2S14039 B2S1404 0 B2S1404 5 B2S1406 5 B2S1406 6
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product || Used for general surgical applications and musculoskeletal procedures to visualize.
  • Model / Serial
    Model Numbers - OEC 9900 Elite
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, and the countries of Australia, Argentina, Canada, China, Cambodia, Columbia, Japan, Ecuador, Japan, Korea, Hong Kong, India, Israel, Libya, Mexico, Nigeria, Peru, Russia, Thailand, Taiwan, Saudi Arabia and Singapore.
  • Product Description
    The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. || Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretion.
  • Model / Serial
    GE Brivo OEC715: Serial Numbers B2S15158 to B2S15164; B2S15166 to B2S15171; B2S15173 to B2S15195; B2S15197; B2S15200; B2S15202; B2S16046; B2S16050; B2S16051  GE Brivo OEC785: Serial Numbers B3S15236; B3S15241; B3S15242; B3S15246; B3S15248; B3S15250; B3S15253 to B3S15257; B3S15259 to B3S15338; B3S15353; B3S15357 to B3S15359; B3S16152  GE Brivo OEC865: Serial Numbers B4S15063 to B4S15070; B4S15072; B4S15073; B4S15075; B4S16029
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, FL, KS, MS, NJ, NV, NY, PA, TX, UT, and WV. No Candaian or Va/govt/military consignees. There are 133 other foreign consignees.
  • Product Description
    OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance || Product Usage: || The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations, injections or biopsy. The OEC Brivo is not indicated for interventional use.
  • Model / Serial
    OEC FlexiView 8800 systems that had NEMA 5-15 15 Amp power cords replaced between January 28, 2016 and November 23, 2016.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    One consignee in CA.
  • Product Description
    OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems
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3 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA