BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    UNIVERSIX 190

    K Number: K953402 · Decision Aug 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    20
    Applicant Total
    190
    Review Days
    22

    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
    UNIVERSIX 190
    K Number
    K953402
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1880
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems (Cleveland), Inc.
    Date Received
    July 20, 1995
    Decision Date
    August 11, 1995
    Product Code
    IXY
    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
    IXY Holder, Radiographic Cassette, Wall-Mounted

    Similar 510(k) Clearances

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

    VRS 3 WALL STAND

    FDA 510(k)
    FDA Class 1 ·Radiology

    SENSORI-MOTOR RATING SCALE

    FDA 510(k)
    FDA Class 1 ·Radiology

    NTBS-1417, 1436, TBS-1417

    FDA 510(k)
    FDA Class 1 ·Radiology

    BC/WT/PF

    FDA 510(k)
    FDA Class 1 ·Radiology

    RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER

    FDA 510(k)
    FDA Class 1 ·Radiology

    WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT

    FDA 510(k)
    FDA Class 1 ·Radiology
    View all

    Other Clearances by Philips Medical Systems (Cleveland), Inc.

    K Number Device Name
    K171850 Philips CT Big Bore
    K172406 Ingenuity TF
    K162838 Philips iCT CT System
    K163711 IQon Spectral CT
    K170086 Pinnacle Radiation Therapy Planning System
    K160743 Philips Ingenuity CT
    K153444 Philips Multislice CT System with Low Dose CT Lung Cancer
    K130992 PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
    K111336 EBW NM 2.0
    K111024 JETPACK 2.0
    Search all 190 clearances from Philips Medical Systems (Cleveland), Inc. →