BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Philips Medical Systems Technologies Ltd.

    Reg #: 3015763655 · FEI: 3015763655 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    28
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    Philips Medical Systems Technologies Ltd.
    Registration Number
    3015763655
    FEI Number
    3015763655
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    MATAM, Building 34
    City
    Haifa
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K250181

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    1217116
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    US Agent

    Business Name
    Philips
    Contact Name
    Martin Pedroza
    Address
    9965 Federal Drive
    City
    Colorado Springs
    State
    CO
    ZIP
    80921
    Country
    US
    Email
    [email protected]
    Phone
    440 2197243

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ
    Radiological Computer-Assisted Triage And Notification Software QAS
    Lung Computed Tomography System, Computer-Aided Detection OEB
    System, X-Ray, Tomography, Computed JAK
    System, Tomography, Computed, Emission KPS
    Automated Radiological Image Processing Software QIH

    Proprietary Names

    AV Viewer XD3 StrokeViewer LVO Triaging CAAS MR Solutions (4D Flow and Strain) NeuroQuant ClearRead CT XV LVAS XV Lung Ventilation Analysis Software System Corridor4DM LDA Lung Density Analysis NeuroQ CT:VQ ECTb IntelliSpace Portal V12.x Advanced Visualization Workspace V15.X CT Lung Ventilation Analysis Software CT LVAS XD XD4 Illumeo v2.x Illumeo CSMC Cardiac Suite AutoQuant PHA 4 ICAD VERALOOK CTC CAD SOFTWARE Imbio CAC Software NM Suite V15.X 3Mensio workstation - Picture archiving and communications system

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device