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

    DST-XL

    K Number: K942837 · Decision Jan 5, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    470
    Applicant Total
    8
    Review Days
    204

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    Basic Information

    Device Name
    DST-XL
    K Number
    K942837
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1200
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sopha Medical Systems, Inc.
    Date Received
    June 15, 1994
    Decision Date
    January 5, 1995
    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 Sopha Medical Systems, Inc.

    K Number Device Name
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    K921008 VECTOR SERIES
    K913641 SOPHY NXT
    K911346 SOPHYCAMERA DSX BODYTRAK
    K894931 SOPHYCAMERA DSX RECTANGULAR
    K872132 SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS
    K872297 DS-7 NUCLEAR MEDICINE GAMMA CAMERA