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

    UXM MODEL 8188

    K Number: K840678 · Decision Mar 16, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    30

    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
    UXM MODEL 8188
    K Number
    K840678
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1610
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Universal X-Ray
    Date Received
    February 15, 1984
    Decision Date
    March 16, 1984
    Product Code
    IZX
    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
    IZX Collimator, Manual, Radiographic

    Similar 510(k) Clearances

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

    RALCO

    FDA 510(k)
    FDA Class 2 ·Radiology

    SHIMADZU COLLIMATOR R-20J

    FDA 510(k)
    FDA Class 2 ·Radiology

    SHIMADZU COLLIMATOR R-20J

    FDA 510(k)
    FDA Class 2 ·Radiology

    SHIMADZU COLLIMATOR R-30H

    FDA 510(k)
    FDA Class 2 ·Radiology

    FACTS MONOBLOCK

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIGHTLINE-M

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all