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

    TILTING RADIOGRAPHIC TABLE (REMOTE)

    K Number: K963851 · Decision Jan 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    76
    Applicant Total
    13
    Review Days
    120

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    Basic Information

    Device Name
    TILTING RADIOGRAPHIC TABLE (REMOTE)
    K Number
    K963851
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1980
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Acoma Medical Imaging, Inc.
    Date Received
    September 25, 1996
    Decision Date
    January 23, 1997
    Product Code
    IXR
    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
    IXR Table, Radiographic, Tilting

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