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

    SOLSTICE XRAY RING MARKER PAD

    K Number: K925892 · Decision May 18, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    182

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    Basic Information

    Device Name
    SOLSTICE XRAY RING MARKER PAD
    K Number
    K925892
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1640
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Solstice Corp.
    Date Received
    November 17, 1992
    Decision Date
    May 18, 1993
    Product Code
    JAC
    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
    JAC System, X-Ray, Film Marking, Radiographic

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