BEUDAMED
    Product Code: IZG FDA class 2 21 CFR 892.1730

    System, X-Ray, Photofluorographic

    Radiology

    A photofluorographic X-ray system captures miniaturized photographic images of the fluorescent output of an image intensifier or fluorescent screen, commonly used in mass screening programs for conditions such as tuberculosis. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is IZG, regulated under 21 CFR 892.1730, within the Radiology medical specialty. This device is eligible for third-party review.

    View on FDA
    510(k)s
    7
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    7
    Years Active
    6

    Research product code IZG in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    IZG
    Device Class
    FDA class 2
    Regulation Number
    892.1730
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K960082 DISCOGRAPHY KIT
    K960146 G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY
    K913436 PXI PNEUMATIC COMPRESSION PADDLE
    K920393 MU125M MOBILE X-RAY SYSTEM
    K910503 DISCOGRAPHY KIT
    K903808 AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT
    K892659 ELECTRODELCA