BEUDAMED
    FDA Registration Active 🇨🇳 China

    Philips Healthcare (Suzhou) Co., Ltd.

    Reg #: 3009529630 · FEI: 3009529630 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    57
    Establishment Types
    4
    Classifications
    13

    Registration Details

    Registration Name
    Philips Healthcare (Suzhou) Co., Ltd.
    Registration Number
    3009529630
    FEI Number
    3009529630
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 258, Zhongyuan Road, Suzhou Industrial Park
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K141381

    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
    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
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Stationary KPR
    System, X-Ray, Tomography, Computed JAK
    System, Tomography, Computed, Emission KPS
    System, Image Processing, Radiological LLZ
    System, Planning, Radiation Therapy Treatment MUJ
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    Catheter, Ultrasound, Intravascular OBJ
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Automated Radiological Image Processing Software QIH
    Coil, Magnetic Resonance, Specialty MOS
    Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer POK

    Proprietary Names

    DuraDiagnost Spectral CT on Rails Ingenuity TF Ingenuity Flex Brilliance 64 BrightView BrightView X SPECT Imaging Systems NM Application Suite 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 Brilliance CT Big Bore Philips CT Big Bore 712201, DigitalDiagnost C50 Brilliance 16 Brilliance 16 Power CT Systems Brilliance 6 Ingenuity Core Ingenuity Core 128 CT Systems Ingenuity Vereos PET/CT Spectral CT 7500 RT GEMINI TF Big Bore PET/CT Imaging System 728351Multimodality Simulation Workspace (MM Sim) 1 Upgrade 728349 Multimodality Simulation Workspace (MM Sim) 1 GEMINI 16 PET/CT Imaging Systems GEMINI TF 64 GEMINI TF 16 Base TruFlight Select GEMINI TF 16 GEMINI TF 16 Ready GEMINI LXL Philips Gemini TF 16 Epiq Series Diagnostic Ultrasound System Affiniti Series Diagnostic Ultrasound System Spectral CT IQon Spectral CT JETPack 2 dS MSK S 1.5T dS TorsoCardiac 1.5T dS MSK M 1.5T DigitalDiagnost C50 BrightView XCT SPECT/CT Imaging System CT Rembra CT Areta RT CT Rembra RT Smart Fit TorsoCardiac 1.5T Philips iCT CT System JETStream Workspace Dual Energy Option for Brilliance iCT Ctsystem Smart Fit Knee 3T Incisive CT CT 5300 Smart Fit Shoulder 1.5T

    Establishment Types

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