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

    RADIOGRAPHIC FILM MARKING SYSTEM

    K Number: K913478 · Decision Oct 15, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    17
    Applicant Total
    8
    Review Days
    70

    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
    RADIOGRAPHIC FILM MARKING SYSTEM
    K Number
    K913478
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1640
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lorad Medical Systems, Inc.
    Date Received
    August 6, 1991
    Decision Date
    October 15, 1991
    Product Code
    JAC
    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
    JAC System, X-Ray, Film Marking, Radiographic

    Similar 510(k) Clearances

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

    DIGITAL I.D. CAMERA

    FDA 510(k)
    FDA Class 1 ·Radiology

    CT/MRI TOPOGRAPHIC MARKER

    FDA 510(k)
    FDA Class 1 ·Radiology

    FUJI EC ID CAMERA

    FDA 510(k)
    FDA Class 1 ·Radiology

    SOLSTICE XRAY RING MARKER PAD

    FDA 510(k)
    FDA Class 1 ·Radiology

    KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L

    FDA 510(k)
    FDA Class 1 ·Radiology

    ADMARK

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

    Other Clearances by Lorad Medical Systems, Inc.

    K Number Device Name
    K921962 LORAD DIGITAL SPOT MAMMOGRAPHY
    K922619 DIGITIZER, MODEL # 3-000A-1518
    K913732 MAMMOGRAPHIC X-RAY SYSTEM
    K894935 S-70 PORTABLE DENTAL X-RAY SYSTEM
    K894643 RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT
    K882875 STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY
    K842102 LORAD