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

    DIGITAL GAMMA CAMERA GCA 601 E

    K Number: K851685 · Decision Jun 14, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    16
    Applicant Total
    54
    Review Days
    52

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    Basic Information

    Device Name
    DIGITAL GAMMA CAMERA GCA 601 E
    K Number
    K851685
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1310
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Toshiba Medical Systems
    Date Received
    April 23, 1985
    Decision Date
    June 14, 1985
    Product Code
    JWM
    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
    JWM System, Tomographic, Nuclear

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