BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    8 Channel Foot Ankle MR Coil Kit 3T

    Reg #: 3003768277 · FEI: 3002807880 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    28
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Registration Number
    3003768277
    FEI Number
    3002807880
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VEENPLUIS 6
    City
    BEST Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K050514

    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
    Coil, Magnetic Resonance, Specialty MOS

    Proprietary Names

    8 Channel Foot Ankle MR Coil Kit 3T Siemens Avanto 1.5T 8Ch FAC (Foot/Ankle Coil) Siemens 8 Channel Foot Ankle MR Coil Kit Verio 3T Philips dS 1.5T 8-ch Foot Ankle Coil Siemens 1.5T AVANTO 8Ch FAC Siemens 1.5T ESPREE 8Ch FAC Philips dS 3T 8-ch Foot Ankle Coil GE HD 1.5T 8C Foot and Ankle GE Excite HDx 1.5T HDx 8Ch 1.5T FAC 8 Channel Foot Ankle MR Coil Kit 1.5T HD 8CH Foot Ankle Coil (Receive Only) Siemens 3T TIM/TRIO 8Ch FAC GE Excite 3T HDx 8Ch FAC SENSE Foot-Ankle Coil GE HD 3T 8C Foot and Ankle GE Excite 1.5T 8Ch Foot and Ankle Coil (FAC) Philips SENSE Foot-Ankle Coil 3T 8ch SMS 1.5T Espree 8Ch FAC (Foot/Ankle Coil) Siemens 3T Tim/Trio 8Ch FAC (Foot/Ankle Coil) Siemens 1.5T Symphony 8Ch FAC Philips SENSE Foot-Ankle Coil 1.5T 8ch dS FOOTANKLE 8CH 1.5T HD 8Ch Foot Ankle Coil 8CH FOOT ANKLE MR COIL 3T 8 CHANNEL FOOT ANKLE COIL 1.5T dS FootAnkle 8Ch 3T SIEMENS 8 CHANNEL FOOT AND ANKLE ARRAY dS Foot-Ankle Coil 8ch 3T

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198