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

    MULTIPLE ACCESSORY TO GAMMA CAMERAS

    K Number: K920962 · Decision Apr 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    74

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MULTIPLE ACCESSORY TO GAMMA CAMERAS
    K Number
    K920962
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1350
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nu Age Products
    Date Received
    February 3, 1992
    Decision Date
    April 17, 1992
    Product Code
    IYZ
    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
    IYZ Bed, Scanning, Nuclear

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IYZ), ordered by most recent decision date.

    SPECT TABLE, MODEL #056-760

    FDA 510(k)
    FDA Class 1 ·Radiology

    XYZ CRANK IMAGING TABLE

    FDA 510(k)
    FDA Class 1 ·Radiology

    ECT CARBON FIBER PALLET, MODIFICATION

    FDA 510(k)
    FDA Class 1 ·Radiology

    CARDIAC SPECT PALLET

    FDA 510(k)
    FDA Class 1 ·Radiology

    XY IMAGING TABLE

    FDA 510(k)
    FDA Class 1 ·Radiology

    E-Z LIFT CRANK IMAGING TABLE

    FDA 510(k)
    FDA Class 1 ·Radiology
    View all