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

    SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096)

    K Number: K944816 · Decision Feb 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    175
    Applicant Total
    190
    Review Days
    132

    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
    SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096)
    K Number
    K944816
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1710
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems (Cleveland), Inc.
    Date Received
    September 29, 1994
    Decision Date
    February 8, 1995
    Product Code
    IZH
    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
    IZH System, X-Ray, Mammographic

    Similar 510(k) Clearances

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

    SMART FINDER

    FDA 510(k)
    FDA Class 2 ·Radiology

    Affirm Contrast Biopsy

    FDA 510(k)
    FDA Class 2 ·Radiology

    Biopsy Positioner

    FDA 510(k)
    FDA Class 2 ·Radiology

    Affirm Lateral Arm Upright Biopsy Accessory

    FDA 510(k)
    FDA Class 2 ·Radiology

    Comfort Cover

    FDA 510(k)
    FDA Class 2 ·Radiology

    Affirm Prone Biopsy System

    FDA 510(k)
    FDA Class 2 ·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. →