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

    FCR GO PORTABLE DIGITAL X-RAY SYSTEM

    K Number: K080945 · Decision Apr 18, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    235
    Applicant Total
    39
    Review Days
    15

    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
    FCR GO PORTABLE DIGITAL X-RAY SYSTEM
    K Number
    K080945
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujifilm Medical Systems U.S.A, Inc.
    Date Received
    April 3, 2008
    Decision Date
    April 18, 2008
    Product Code
    IZL
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IZL System, X-Ray, Mobile

    Similar 510(k) Clearances

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

    Portable DR Imaging System

    FDA 510(k)
    FDA Class 2 ·Radiology

    RAYMO Mobile X-ray System (Model: RAYMO)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System

    FDA 510(k)
    FDA Class 2 ·Radiology

    AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Airbile-100

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mobile X-ray unit (!M1)

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

    Other Clearances by Fujifilm Medical Systems U.S.A, Inc.

    K Number Device Name
    K171291 FUJIFILM Bronchoscope Model EB-530P
    K171207 FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
    K173132 ASPIRE Cristalle
    K171463 ASPIRE Bellus II
    K152257 Fujifilm Duodenoscope Model ED-530XT
    K163624 Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
    K162749 FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
    K171096 Fujifilm Diathermic Slitter (FlushKnife)
    K170858 FDR AQRO (DR-XD 1000)
    K162287 Synapse 3D Perfusion Analysis
    Search all 39 clearances from Fujifilm Medical Systems U.S.A, Inc. →