BEUDAMED
    FDA Registration Active 🇮🇳 India

    Philips India Limited - Image Guided Therapy Systems Business Unit

    Reg #: 3033527282 · FEI: 3033527282 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    30
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    Philips India Limited - Image Guided Therapy Systems Business Unit
    Registration Number
    3033527282
    FEI Number
    3033527282
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Philips Innovation Campus, Embassy Business Hub, Venkatala Village, Yelahanka Hobli, Yelahanka
    City
    Bengaluru Karnataka
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K200917

    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 MEDICAL SYSTEMS INTERNATIONAL BV
    Contact Name
    Maria Heiling
    Address
    3721 Valley Centre Dr., Ste. 500
    City
    San Diego
    State
    CA
    ZIP
    92130
    Country
    US
    Email
    [email protected]
    Phone
    858 2487651

    Products

    Device Name Product Code
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    System, Image Processing, Radiological LLZ
    System, X-Ray, Tomography, Computed JAK
    System, X-Ray, Angiographic IZI

    Proprietary Names

    Azurion 7 B20 Azurion 5 M12 Azurion 3 M12 Azurion 3 M15 Azurion 7 M12 Azurion 7 M20 Azurion 5 M20 Azurion 7 B12 MR-CT Roadmap Rel. 1 Allura 3D-RA Rel. 6 3D Roadmap Rel. 1 3D-RA ALLURACLARITY XPER FD SERIES X-RAY SYSTEM Dynamic Coronary Roadmap 2 Allura Xper FD series and Allura Xper OR Table series Interventional Workspot Allura 3D-CA 3D-CA CT TrueView EmboGuide R1 XperGuide StentBoost Live Heart Navigator Release 2 AneurysmFlow Stentboost R4.2 SmartCT XperCT Rel. 3 VesselNavigator EP Navigator R5 CT TrueView - 001010

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility