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

    XPRESS

    K Number: K903701 · Decision Nov 7, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    146
    Review Days
    84

    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
    XPRESS
    K Number
    K903701
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Toshiba America Medical Systems, In.C
    Date Received
    August 15, 1990
    Decision Date
    November 7, 1990
    Product Code
    JAK
    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
    JAK System, X-Ray, Tomography, Computed

    Similar 510(k) Clearances

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

    Respiratory Gating for Scanners (2.1)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Aquilion ONE (TSX-308A/TSX-306A) V2.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    Spectral CT Verida Family

    FDA 510(k)
    FDA Class 2 ·Radiology

    True Definition DL

    FDA 510(k)
    FDA Class 2 ·Radiology

    CT Rembra RT; CT Areta RT; CT Rembra

    FDA 510(k)
    FDA Class 2 ·Radiology

    SOMATOM X.cite; SOMATOM X.ceed

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

    Other Clearances by Toshiba America Medical Systems, In.C

    K Number Device Name
    K141472 VANTAGE ELAN
    K133553 KALARE
    K140729 APLIO ARTIDA, V3.2
    K132106 INFINIX ANGIO WORKSTATION W/DTS SOFTWARE
    K131822 ULTRAEXTEND USWS-900A V2.1 AND V3.1
    K123097 DOSE TRACKING SYSTEM MODEL XIDF-DTS801
    K122613 VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US
    K121076 ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE
    K122842 RADREX-I, SW V4.00 MODEL DRAD-3000E
    K122109 AQUILION ONE VISION, V4.90
    Search all 146 clearances from Toshiba America Medical Systems, In.C →