Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K081757
    Device Name
    VERISTA IMAGING ISOCAM II GAMMA CAMERA
    Date Cleared
    2008-08-15

    (56 days)

    Product Code
    Regulation Number
    892.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERISTA IMAGING INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Verista Imaging ISOCAM II Gamma Camera is intended to image the distribution of radionuclides in the body by means of photon radiation detector(s).
    Device Description
    The ISOCAM II Gamma Camera is a medical imaging device used in nuclear medicine. It produces gamma ray distribution emitting radionuclides. It consists of one or more detectors mounted on a gantry that is connected to an acquisition system for operating the camera and storing the images. The base unit is a nuclear imaging device which utilizes gamma ray scintillation technologies. The modification to the device is limited to an upgrade to the mechanical operation of the device. The modifications improve patient safety through changes to the arm drive mechanical components and the addition of a weighted counter balance system.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1