BEUDAMED
    FDA Registration Active 🇺🇸 United States

    XL14-3

    Reg #: 2518586 · FEI: 2518586 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    53
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Philips Ultrasound LLC
    Registration Number
    2518586
    FEI Number
    2518586
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Echo Dr
    City
    Reedsville
    State
    PA
    ZIP
    17084
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181485

    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
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    XL14-3 X8-2t C8-5 S4-2 S9-2 X7-2t C10-3v S8-3 EPIQ 7C Diagnostic Ultrasound System EPIQ 5C Diagnostic Ultrasound System C6-2 X5-1 L18-5 D2tcd C5-1 EPIQ 7W Diagnostic Ultrasound System D2cwc L12-5 50 C9-4v S7-3t Affiniti 50W Diagnostic Ultrasound System X6-1 Affiniti 50 Diagnostic Ultrasound System EPIQ 5G Diagnostic Ultrasound System EPIQ Diagnostic Ultrasound System EPIQ 5W Diagnostic Ultrasound System EPIQ 5 Diagnostic Ultrasound System eL18-4 Affiniti 50G Diagnostic Ultrasound System EPIQ 7 Diagnostic Ultrasound System Affiniti 50C Diagnostic Ultrasound System V6-2 Affiniti 70W Diagnostic Ultrasound System EPIQ 7G Diagnostic Ultrasound System BP10-5ec EPIQ CVxi Diagnostic Ultrasound System VL13-5 3D9-3v L15-7io L12-4 X8-2ti S12-4 S5-1 Affiniti 70G Diagnostic Ultrasound System Affiniti 70 Diagnostic Ultrasound System D5cwc EPIQ CVx Diagnostic Ultrasound System C10-4ec Affiniti 70C Diagnostic Ultrasound System L12-3 C9-2 S8-3t X7-2

    Establishment Types

    Manufacture Medical Device