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

    R605 FACS COLLIMETER

    K Number: K050092 · Decision Jan 31, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    22
    Applicant Total
    8
    Review Days
    17

    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
    R605 FACS COLLIMETER
    K Number
    K050092
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1610
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Omega Medical Imaging, Inc.
    Date Received
    January 14, 2005
    Decision Date
    January 31, 2005
    Product Code
    IZW
    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
    IZW Collimator, Automatic, Radiographic

    Similar 510(k) Clearances

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

    SHIMADZU COLLIMATOR R-300

    FDA 510(k)
    FDA Class 2 ·Radiology

    R650 QDASM COLLIMATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    SHIMADZU COLLIMATOR R-30H

    FDA 510(k)
    FDA Class 2 ·Radiology

    RALCO, MODEL R225 ACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR

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

    Other Clearances by Omega Medical Imaging, Inc.

    K Number Device Name
    K100102 CS-SERIES-FP
    K093572 R650 QDASM COLLIMATOR
    K070834 CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)
    K062647 E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50
    K990055 B-400 CEILING MOUNTED POSSITIONER, MODEL B-400
    K970947 B-350 CEILING MOUNTED C-POSITIONER
    K902005 MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE