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

    PRONOSCO X-POSURE SYSTEM

    K Number: K984178 · Decision Feb 18, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    146
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    PRONOSCO X-POSURE SYSTEM
    K Number
    K984178
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1170
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Torsana Osteoporosis Diagnostics A/S
    Date Received
    November 20, 1998
    Decision Date
    February 18, 1999
    Product Code
    KGI
    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
    KGI Densitometer, Bone

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