BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇰 Denmark

    CAPIMAGE

    K Number: K081829 · Decision Jul 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    129
    Applicant Total
    6
    Review Days
    14

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    Basic Information

    Device Name
    CAPIMAGE
    K Number
    K081829
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1100
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Danish Diagnostic Development A/S
    Date Received
    June 27, 2008
    Decision Date
    July 11, 2008
    Product Code
    IYX
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IYX Camera, Scintillation (Gamma)

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