BEUDAMED
    FDA Registration Active 🇺🇸 United States

    L12-5 50

    Reg #: 2518586 · FEI: 2518586 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    59
    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
    K182857

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

    Proprietary Names

    L12-5 50 mC7-2 Affiniti 50C Diagnostic Ultrasound System X7-2 S12-4 eL18-4 S5-1 C10-3v Affiniti 50W Diagnostic Ultrasound System EPIQ CVxi Diagnostic Ultrasound System S7-3t X8-2ti S8-3t EPIQ 5 Diagnostic Ultrasound System Affiniti 50 Diagnostic Ultrasound System EPIQ 5C Diagnostic Ultrasound System EPIQ 5W Diagnostic Ultrasound System L15-7io EPIQ 7W Diagnostic Ultrasound System Affiniti 50G Diagnostic Ultrasound System EPIQ CVx Diagnostic Ultrasound System EPIQ 7 Diagnostic Ultrasound System C9-2 C9-4v VL13-5 Affiniti 70C Diagnostic Ultrasound System C5-1 C10-4ec V9-2 D5cwc L18-5 EPIQ 5G Diagnostic Ultrasound System D2tcd BP10-5ec L12-3 ERGO EPIQ Diagnostic Ultrasound System EPIQ 7G Diagnostic Ultrasound System X5-1 S9-2 Affiniti 70G Diagnostic Ultrasound System L12-4 X6-1 L12-3 C6-2 X7-2t EPIQ Elite W Diagnostic Ultrasound System S4-2 EPIQ 7C Diagnostic Ultrasound System S8-3 EPIQ Elite Diagnostic Ultrasound System C8-5 Affiniti 70 Diagnostic Ultrasound System V6-2 3D9-3v D2cwc Affiniti 70W Diagnostic Ultrasound System XL14-3 X8-2t X5-1c

    Establishment Types

    Manufacture Medical Device