BEUDAMED
    FDA Registration Active 🇨🇳 China

    EPIQ Diagnostic Ultrasound Systems

    Reg #: 3009529630 · FEI: 3009529630 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Philips Healthcare (Suzhou) Co., Ltd.
    Registration Number
    3009529630
    FEI Number
    3009529630
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 258, Zhongyuan Road, Suzhou Industrial Park
    City
    Suzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K201012

    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
    Transducer, Ultrasonic, Diagnostic ITX
    Automated Radiological Image Processing Software QIH
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    EPIQ Diagnostic Ultrasound Systems Affiniti Diagnostic Ultrasound Systems Cx50 Diagnostic Ultrasound System Lumify Diagnostic Ultrasound System QLAB Advanced Quantification Software Sparq Diagnostic Ultrasound System EPIQ Circular Edition Diagnostic Ultrasound System Sparq Diamond Select Diagnostic Ultrasound System Lumify Diamond Select Diagnostic Ultrasound System Sparq Circular Edition Diagnostic Ultrasound System Affiniti Circular Edition Diagnostic Ultrasound System CX50 Diamond Select Diagnostic Ultrasound System CX50 Circular Edition Diagnostic Ultrasound System Lumify Circular Edition Diagnostic Ultrasound System

    Establishment Types

    Manufacture Medical Device