BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EPIQ 7 Diagnostic Ultrasound System;

    Reg #: 3019216 · FEI: 3019216 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    21
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    Philips Ultrasound LLC
    Registration Number
    3019216
    FEI Number
    3019216
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    22100 Bothell Everett Hwy
    City
    BOTHELL
    State
    WA
    ZIP
    98021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240980

    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

    Products

    Device Name Product Code
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX
    Automated Radiological Image Processing Software QIH
    Catheter, Ultrasound, Intravascular OBJ
    System, Imaging, Pulsed Doppler, Ultrasonic IYN

    Proprietary Names

    EPIQ 7 Diagnostic Ultrasound System; EPIQ 5W Diagnostic Ultrasound System; EPIQ 5 Diamond Select Ultrasound System; EPIQ Elite Diamond Select Ultrasound System; EPIQ 5 Diagnostic Ultrasound System; EPIQ 7W Diagnostic Ultrasound System; EPIQ CVx Diamond Select Ultrasound System; EPIQ 5 Circular Edition Ultrasound System; EPIQ 7 Circular Edition Ultrasound System; EPIQ 7 Diamond Select Ultrasound System; EPIQ 7C Diagnostic Ultrasound System; EPIQ 5C Diagnostic Ultrasound System; EPIQ 5G Diagnostic Ultrasound System; EPIQ CVx Circular Edition Ultrasound System; EPIQ Elite Circular Edition Ultrasound System; EPIQ CVx Diagnostic Ultrasound System; EPIQ Elite Diagnostic Ultrasound System; EPIQ Diagnostic Ultrasound System; EPIQ 7G Diagnostic Ultrasound System; EPIQ CVxi Diagnostic Ultrasound System; EPIQ Elite W Diagnostic Ultrasound System;

    Establishment Types

    Manufacture Medical Device