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510(k) Data Aggregation

    K Number
    K053086
    Device Name
    MIE - GAMMA CAMERA SYSTEMS
    Manufacturer
    Date Cleared
    2006-01-27

    (86 days)

    Product Code
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIE AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MIE - Gamma Camera Systems for nuclear medicine, are used to perform static, dynamic and gated studies, as well as spect or planar procedure, on standing, seated or recumbent patients
    Device Description
    All MiE remanufactured Gamma Camera System have 3 functional units equivalent to the Siemens or GE Gamma Camera Systems. The modification to the SIEMENS- or GE-Gamma Camera System consisted of removal of certain low voltage cicuit boards in the gamma Camera and the gantry portions of the Siemens – or GE Gamma Camera System and installing proprietary low voltage circuit board that allow the use of our SCINTRON Computer and its software. All MIE Gamma Camera Systems consist of the same detector unit that is in use in the Siemens- or GE Gamma Camera System. The mechanical units (camera head with its supporting beam) hold the detector and make sure it can be moved around or along the patient for the optimal diagnostic procedure. The only difference to the basic SIEMENS or GE Gamma Camera system consists in our own imaging and processing software SCINTRON (already cleared by the FDA, K953193).
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