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

    AQUILION ONE

    K Number: K113466 · Decision Apr 10, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    795
    Applicant Total
    5
    Review Days
    140

    Basic Information

    Device Name
    AQUILION ONE
    K Number
    K113466
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
    Date Received
    November 22, 2011
    Decision Date
    April 10, 2012
    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.

    SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse

    FDA 510(k)
    FDA Class 2 ·Radiology

    Philips iCT CT system

    FDA 510(k)
    FDA Class 2 ·Radiology

    CT Scanner TSX-501R/1 V11.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    CardIQ Suite

    FDA 510(k)
    FDA Class 2 ·Radiology

    SCENARIA View Phase 5.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    Spectral CT

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

    Other Clearances by TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN

    K Number Device Name
    K121422 APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM
    K112366 4CH FLEX SPEEDER
    K110785 KALARE DIAGNOSTIC X-RAY TABLE SYSTEM
    K111251 4CH FLEX SPEEDER