BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SUMMIT NUCLEAR VISION T-22 GAMMA CAMERA SYSTEM

    K Number: K922426 · Decision Sep 28, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    6
    Review Days
    129

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    Basic Information

    Device Name
    SUMMIT NUCLEAR VISION T-22 GAMMA CAMERA SYSTEM
    K Number
    K922426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Summit Nuclear
    Date Received
    May 22, 1992
    Decision Date
    September 28, 1992
    Product Code
    KPS
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KPS System, Tomography, Computed, Emission

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    Other Clearances by Summit Nuclear

    K Number Device Name
    K935273 VISION FX 40 & 80 SERIES GAMMA CAMERA
    K935318 SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS
    K922427 SUMMIT NUCLEAR VISION 1024RZ GAMMA CAMERA SYSTEM
    K920958 SUMMIT NUCLEAR VISION NEUROSPECT
    K912573 VISION (NUCLEAR MEDICINE COMPUTER)