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

    X-RAY TUBESTANDS BUCKY STANDS & VETERINARY X-RAY

    K Number: K844337 · Decision Feb 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    39
    Applicant Total
    1
    Review Days
    105

    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
    X-RAY TUBESTANDS BUCKY STANDS & VETERINARY X-RAY
    K Number
    K844337
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1770
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Quality X-Ray Manufacturing, Inc.
    Date Received
    November 8, 1984
    Decision Date
    February 21, 1985
    Product Code
    IYB
    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
    IYB Tube Mount, X-Ray, Diagnostic

    Similar 510(k) Clearances

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

    SUPERSTAND 300

    FDA 510(k)
    FDA Class 1 ·Radiology

    MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000

    FDA 510(k)
    FDA Class 1 ·Radiology

    F/C/W TUBESTAND

    FDA 510(k)
    FDA Class 1 ·Radiology

    CTS SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    MPR-814

    FDA 510(k)
    FDA Class 1 ·Radiology

    MODEL ALPHA TS-2

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