BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Philips Medical Systems Nederland B.V.

    Reg #: 3015777306 · FEI: 3015777306 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    41
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Philips Medical Systems Nederland B.V.
    Registration Number
    3015777306
    FEI Number
    3015777306
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Veenpluis 6
    City
    Best Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K240844

    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
    100 Park Avenue, Suite 300
    City
    Orange Village
    State
    OH
    ZIP
    44122
    Country
    US
    Email
    [email protected]
    Phone
    440 2197243

    Products

    Device Name Product Code
    System, X-Ray, Tomography, Computed JAK
    System, Tomography, Computed, Emission KPS
    System, Image Processing, Radiological LLZ
    System, Planning, Radiation Therapy Treatment MUJ

    Proprietary Names

    Spectral CT 7500 RT GEMINI 16 PET/CT Imaging Systems BrightView BrightView X SPECT Imaging Systems Philips iCT CT System NM Application Suite Spectral CT on Rails Spectral CT 728351Multimodality Simulation Workspace (MM Sim) 1 Upgrade 728349 Multimodality Simulation Workspace (MM Sim) 1 JETStream Workspace Brilliance CT Big Bore Philips CT Big Bore GEMINI TF Big Bore PET/CT Imaging System Upgrade Spectral CT Verida RT Spectral CT Verida Upgrade Spectral CT Verida Upgrades Spectral CT 7500 RT SW5.4 Spectral CT Verida RT Upgrade Spectral CT 7500 SW5.4 Dual Energy Option for Brilliance iCT Ctsystem GEMINI TF 64 GEMINI TF 16 Base TruFlight Select GEMINI TF 16 GEMINI TF 16 Ready GEMINI LXL Philips Gemini TF 16 Ingenuity TF Ingenuity Flex Brilliance 64 Ingenuity Core Ingenuity Core 128 CT Systems Ingenuity BrightView XCT SPECT/CT Imaging System Vereos PET/CT Brilliance 16 Brilliance 16 Power CT Systems Brilliance 6 IQon Spectral CT JETPack 2

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility