BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS

    K Number: K872132 · Decision Oct 26, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    20
    Applicant Total
    8
    Review Days
    145

    Basic Information

    Device Name
    SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS
    K Number
    K872132
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1880
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    SOPHA MEDICAL SYSTEMS, INC.
    Date Received
    June 3, 1987
    Decision Date
    October 26, 1987
    Product Code
    IXY
    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
    IXY Holder, Radiographic Cassette, Wall-Mounted

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    K913641 SOPHY NXT
    K911346 SOPHYCAMERA DSX BODYTRAK
    K894931 SOPHYCAMERA DSX RECTANGULAR
    K872297 DS-7 NUCLEAR MEDICINE GAMMA CAMERA