BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Ingenuity Digital PET/CT System

    Reg #: 3015777306 · FEI: 3015777306 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Philips Medical Systems Nederland B.V.
    Registration Number
    3015777306
    FEI Number
    3015777306
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Veenpluis 6
    City
    Best Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K123599

    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

    Proprietary Names

    Ingenuity Digital PET/CT System Vereos PET/CT

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility