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

    FUJI DAYLIGHT CASSETTE MULTI-LOADER

    K Number: K933408 · Decision Aug 16, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    82
    Applicant Total
    71
    Review Days
    35

    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
    FUJI DAYLIGHT CASSETTE MULTI-LOADER
    K Number
    K933408
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujifilm Medical System U.S.A., Inc.
    Date Received
    July 12, 1993
    Decision Date
    August 16, 1993
    Product Code
    IXW
    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
    IXW Processor, Radiographic-Film, Automatic

    Similar 510(k) Clearances

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

    XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT

    FDA 510(k)
    FDA Class 2 ·Radiology

    INTRAX FILM PROCESSOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX

    FDA 510(k)
    FDA Class 2 ·Radiology

    RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000

    FDA 510(k)
    FDA Class 2 ·Radiology

    FILM PROCESSOR, MODEL LIFE RAY PRO 2500

    FDA 510(k)
    FDA Class 2 ·Radiology

    FILM PROCESSOR, MODEL LIFE RAY PRO 1000

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

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

    K Number Device Name
    K163675 Processor VP-7000, Light Source BL-7000
    K153206 Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
    K151474 Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
    K152138 FDR D-EVO GL Flat Panel Detector System
    K150221 EPX-4440HD and EPX-4400HD with FICE
    K142629 EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
    K142003 FDR D-EVO II FLAT PANEL DETECTOR SYSTEM
    K133976 FUJIFILM ENDOSCOPIC CO2 REGULATOR
    K132188 MAMMOGRAPHY VIEWER SMV658
    K130542 SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
    Search all 71 clearances from Fujifilm Medical System U.S.A., Inc. →