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

    FLUOROSCOPIC BRIGHTNESS STABALIZER/FBS MODEL 9205A

    K Number: K926064 · Decision Apr 27, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    297
    Applicant Total
    2
    Review Days
    147

    Basic Information

    Device Name
    FLUOROSCOPIC BRIGHTNESS STABALIZER/FBS MODEL 9205A
    K Number
    K926064
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SCIENTIFIC TECHNOLOGY LTD.
    Date Received
    December 1, 1992
    Decision Date
    April 27, 1993
    Product Code
    JAA
    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
    JAA System, X-Ray, Fluoroscopic, Image-Intensified

    Similar 510(k) Clearances

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

    Soteria E-View

    FDA 510(k)
    FDA Class 2 ·Radiology

    Adora DRFi (04550010)

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRIDENT Mobile Fluoroscopy System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ProxiDiagnost N90 / Precision CRF (706110, 706400)

    FDA 510(k)
    FDA Class 2 ·Radiology

    CombiDiagnost R90

    FDA 510(k)
    FDA Class 2 ·Radiology

    XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5

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

    Other Clearances by SCIENTIFIC TECHNOLOGY LTD.

    K Number Device Name
    K902848 FASTRECON 88 PERIFERAL