BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.

    Reg #: 9617978 · FEI: 3008581796 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    46
    Establishment Types
    4
    Classifications
    4

    Registration Details

    Registration Name
    PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.
    Registration Number
    9617978
    FEI Number
    3008581796
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ADVANCED TECHNOLOGY CENTER, MATAM BUILDING 34
    City
    HAIFA
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K212875

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

    Proprietary Names

    Incisive CT Spectral CT on Rails GEMINI 16 PET/CT Imaging Systems Dual Energy Option for Brilliance iCT Ctsystem Vereos PET/CT GEMINI TF Big Bore PET/CT Imaging System Brilliance CT Big Bore Philips CT Big Bore Ingenuity Core Ingenuity Core 128 CT Systems Ingenuity Spectral CT 7500 RT Philips iCT CT System Ingenuity TF NM Application Suite Brilliance 16 Brilliance 16 Power CT Systems Brilliance 6 GEMINI TF 64 GEMINI TF 16 Base TruFlight Select GEMINI TF 16 GEMINI TF 16 Ready GEMINI LXL Philips Gemini TF 16 IQon Spectral CT CT Rembra CT Areta RT CT Rembra RT JETPack 2 CT 5300 JETStream Workspace Ingenuity Flex Brilliance 64 BrightView BrightView X SPECT Imaging Systems 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 BrightView XCT SPECT/CT Imaging System Spectral CT 728351Multimodality Simulation Workspace (MM Sim) 1 Upgrade 728349 Multimodality Simulation Workspace (MM Sim) 1

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility