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

    GE OEC FLUOROSTAR

    K Number: K043076 · Decision Dec 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    319
    Applicant Total
    11
    Review Days
    44

    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
    GE OEC FLUOROSTAR
    K Number
    K043076
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ge Oec Medical Systems, Inc.
    Date Received
    November 8, 2004
    Decision Date
    December 22, 2004
    Product Code
    OWB
    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
    OWB Interventional Fluoroscopic X-Ray System

    Similar 510(k) Clearances

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

    C-beam

    FDA 510(k)
    FDA Class 2 ·Radiology

    Intelligent NR

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTIS genio floor; ARTIS icono.explore floor

    FDA 510(k)
    FDA Class 2 ·Radiology

    BELLIGER ACE

    FDA 510(k)
    FDA Class 2 ·Radiology

    Trinias

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

    Other Clearances by Ge Oec Medical Systems, Inc.

    K Number Device Name
    K233669 OEC 3D
    K203346 OEC 3D
    K192819 OEC Elite
    K172550 OEC Elite
    K171565 OEC Elite
    K132027 OEC 9800 PLUS
    K111551 OEC(R) 9800, OEC(R) 9800 PLUS
    K051490 GE OEC EVERVIEW 7500
    K041931 OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION
    K041932 OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM
    Search all 11 clearances from Ge Oec Medical Systems, Inc. →