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

    STANDARD IMAGING HDR 1000 ION CHAMBER

    K Number: K922554 · Decision Aug 24, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    206
    Applicant Total
    10
    Review Days
    87

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    Basic Information

    Device Name
    STANDARD IMAGING HDR 1000 ION CHAMBER
    K Number
    K922554
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Standard Imaging, Inc.
    Date Received
    May 29, 1992
    Decision Date
    August 24, 1992
    Product Code
    JAQ
    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
    JAQ System, Applicator, Radionuclide, Remote-Controlled

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