BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    GEMINI TF Big Bore PET/CT Imaging System

    Reg #: 9617978 · FEI: 3008581796 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.
    Registration Number
    9617978
    FEI Number
    3008581796
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ADVANCED TECHNOLOGY CENTER, MATAM BUILDING 34
    City
    HAIFA
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K081135

    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, Tomography, Computed, Emission KPS

    Proprietary Names

    GEMINI TF Big Bore PET/CT Imaging System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device