Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K010772
    Device Name
    ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM
    Date Cleared
    2001-08-23

    (162 days)

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

    IMAGING SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

    K Number
    K955251
    Device Name
    OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM
    Date Cleared
    1996-04-12

    (149 days)

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

    IMAGING SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Not Found
    Device Description
    The OEC 902 C-Arm frame, X-Ray Generator, X-Ray Control, Control Panel, Electrical Systems remain the same. Imaging Services, Inc. takes an OEC 902 and repaints it. We repair all mechanical brakes, replace the wheels with the new wheels rated for a greater weight, repair or replace motor drive assemblies with original or comparable replacement parts, repair all electronic systems, then calibrate the X-Ray generator to manufacture specifications using the OEC 902 Service Manual. Then we add a new 9/6 Image Intensifier and CCD Camera system. The CCD Camera System is calibrated to North American Imaging and Imaging Services Specifications. The ABS system utilizes original manufacturer's specifications, wiring and its electronic path remains the same. The wiring of the CCD Camera system uses original wires provided by the original camera system which was deinstalled. The interface between the C-Arm and monitor cart. also utilizes existing wiring as well as spares provided by OEC when the unit was originally manufactured.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1