BEUDAMED
    FDA Registration Active 🇺🇸 United States

    L12-4

    Reg #: 2518586 · FEI: 2518586 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    50
    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
    K172607

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

    Proprietary Names

    L12-4 EPIQ 5W Diagnostic Ultrasound System X14-3 Affiniti 50 Diagnostic Ultrasound System D2tcd V6-2 EPIQ 7C Diagnostic Ultrasound System X7-2 S5-1 C9-4v X6-1 EPIQ 7G Diagnostic Ultrasound System C8-5 VL13-5 Affiniti 70G Diagnostic Ultrasound System S8-3t X8-2t S4-2 Affiniti 50W Diagnostic Ultrasound System C9-2 Affiniti 70W Diagnostic Ultrasound System eL18-4 D5cwc 3D9-3v L15-7io Affiniti 70C Diagnostic Ultrasound System C10-4ec D2cwc S7-3t Affiniti 70 Diagnostic Ultrasound System L12-3 BP10-5ec C6-2 EPIQ 7W Diagnostic Ultrasound System L12-5 50 X5-1 S8-3 EPIQ 5G Diagnostic Ultrasound System EPIQ 7 Diagnostic Ultrasound System EPIQ 5C Diagnostic Ultrasound System Affiniti 50C Diagnostic Ultrasound System S12-4 L18-5 C5-1 C10-3v X7-2t X8-2ti EPIQ Diagnostic Ultrasound System EPIQ 5 Diagnostic Ultrasound System Affiniti 50G Diagnostic Ultrasound System

    Establishment Types

    Manufacture Medical Device