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510(k) Data Aggregation

    K Number
    K000221
    Device Name
    SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM
    Manufacturer
    GE DEC MEDICAL SYSTEMS
    Date Cleared
    2000-04-11

    (78 days)

    Product Code
    OWB, JAA, OXO
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE DEC MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993687
    Device Name
    UROVIEW 2800
    Manufacturer
    GE DEC MEDICAL SYSTEMS
    Date Cleared
    1999-12-21

    (50 days)

    Product Code
    OWB
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE DEC MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include but are not limited to urologic and endoscopic procedures. The system may be used for other imaging applications at the physician's discretion.
    Device Description
    The UroView 2800 is a fluoroscopic x-ray system including a tilting patient-support table with overhead x-ray tube assembly, high-voltage x-ray generator, image intensifier, and video image display. A separate mobile workstation provides digital image processing, image storage capability, and additional video display.
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    K Number
    K992506
    Device Name
    MINI 6800 DIGITAL MOBILE C-ARM
    Manufacturer
    GE DEC MEDICAL SYSTEMS
    Date Cleared
    1999-08-19

    (23 days)

    Product Code
    OXO
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE DEC MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MINI 6800 Digital Mobile C-arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging.
    Device Description
    The OEC mobile workstation, which supports image display monitors, image processing and recording devices, is combined with a miniature C-arm to create the MINI 6800 Digital Mobile C-arm. Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for North American markets, CCIR format for international markets, and DICOM 3.0. The MINI 6800 has the following physical characteristics: - . All components are contained in one mobile workstation. - . An articulating arm is attached to the workstation and extends out from the main cabinet to position the x-ray imaging components. - . All mechanical positioning of the workstation and articulating arm is manual (nonmotorized). - . The system is powered by a non-detachable power cord. - Power ratings between 100-240 VAC, 4-6 Amps at 50/60 Hz. . - . Internal system power is insulated from input power by an isolation transformer. - Fluoroscopic operation: . - -- 40 to 80 kVp - -- 20 to 160 µA (0.020 to 0.160 mA) - Automatic Exposure Rate Control Major components of the system include: - Dual video monitors . - Input isolation transformer . - Digital image processing and x-ray control . - Monoblock X-ray tube and high-voltage power supply . - lmage intensifier ●
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    K Number
    K974355
    Device Name
    INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)
    Manufacturer
    GE DEC MEDICAL SYSTEMS
    Date Cleared
    1998-02-17

    (90 days)

    Product Code
    OWB, JAA, OXO
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE DEC MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMDIS is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
    Device Description
    The IMDIS is comprised of two mobile units: a C-arm stand and a workstation. The C-arm stand supports the high-voltage generator, x-ray controls, and a "C" shaped apparatus which supports an x-ray tube on one end and an image intensifier on the other. The Carm is designed to perform linear and rotational motions which allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The mobile workstation, supports image display monitors, image processing and recording devices. Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for domestic markets, CCIR format for international markets, and DICOM 3.0. An auxiliary connection is provided for a Medrad angiographic injector system to facilitate synchronized acquisition of angiographic images during contrast media iniection.
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    K Number
    K970063
    Device Name
    SERIES 7600 MOBILE DIGITAL C-ARM
    Manufacturer
    GE DEC MEDICAL SYSTEMS
    Date Cleared
    1997-03-11

    (63 days)

    Product Code
    OWB, JAA, OXO
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE DEC MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Series 7600 Mobile Digital C-arm is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
    Device Description
    The Series 7600 system is comprised of two mobile units: the C-arm unit supports the high-voltage generator, x-ray components and x-ray controls; and the other unit, a mobile workstation, supports image display monitors, image processing and recording devices. The C-arm includes a "C" shaped arm that supports an x-ray tube on one end and an image intensifier on the other. The Carm is designed to perform linear and rotational motions which allow the user to position the x-ray imaging components at various angles and distances with respect to the patient.
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    K Number
    K963952
    Device Name
    SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM
    Manufacturer
    GE DEC MEDICAL SYSTEMS
    Date Cleared
    1996-12-23

    (82 days)

    Product Code
    OWB, JAA, OXO
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE DEC MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Series 9600 Mobile Digital Imaging System is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
    Device Description
    The Series 9600 system is comprised of two mobile units: the C-arm unit supports the high-voltage generator, x-ray components and x-ray controls; and the other unit, a mobile workstation, supports image display monitors, image processing and recording devices. The C-arm includes a "C" shaped arm that supports an x-ray tube on one end and an image intensifier on the other. The Carm is designed to perform linear and rotational motions which allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for domestic markets, CCIR format for international markets, and DICOM 3.0.
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