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

    ASPIRE HD PLUS, ASPIRE HD-S

    K Number: K121674 · Decision Sep 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    54
    Applicant Total
    71
    Review Days
    107

    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
    ASPIRE HD PLUS, ASPIRE HD-S
    K Number
    K121674
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1715
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fujifilm Medical System U.S.A., Inc.
    Date Received
    June 6, 2012
    Decision Date
    September 21, 2012
    Product Code
    MUE
    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
    MUE Full Field Digital, System, X-Ray, Mammographic

    Similar 510(k) Clearances

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

    MAMMOMAT B.brilliant (11372950)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Bellalun 2D (VDMS-1000S)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright

    FDA 510(k)
    FDA Class 2 ·Radiology

    HESTIA

    FDA 510(k)
    FDA Class 2 ·Radiology

    2430TCA with Xmaru W

    FDA 510(k)
    FDA Class 2 ·Radiology

    VIVIX-M

    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. →