BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    SENTINELLE BREAST MRI 16CH Tabletop for Siemens 1.5T

    Reg #: 3003768277 · FEI: 3002807880 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    27
    Establishment Types
    2
    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
    K112112

    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

    SENTINELLE BREAST MRI 16CH Tabletop for Siemens 1.5T 8Ch Medial Coil Sen 1.5T 4Ch Left Lateral Coil Sen 1.5T 1Ch Left Coil Element Sen 3T Single Loop Coil Left VS 1Ch Right Coil Element Sen 3T Interface Box VS 16Ch Medial Plug Sen 3T 1Ch Right Coil Element Sen 1.5T Sentinelle Breast MRI Tabletop with 16 Channel Coil Array For Siemens 1.5/3T MRI Systems 4Ch Right Lateral Coil Sen 1.5T 1Ch Left Coil Element Sen 1.5T Single Loop Coil Right VS 16Ch Interface Box Breast Coil Sen 3T Medial Plug Sen 1.5T Medial Array Coil VS 16Ch Lateral Array Coil Left VS 16Ch Lateral Array Coil Right VS 16Ch 4Ch Left Lateral Coil Sen 3T 4Ch Right Lateral Coil Sen 3T 16Ch Interface Box Breast Coil Sen 1.5T PATIENT SUPPORT BREAST SEN 8Ch Medial Coil Sen 3T Medial Plug VS Vanguard for Siemens Breast MRI Auxillary Table SENTINELLE BREAST MRI 16CH Tabletop for Siemens 3T SENTINELLE BREAST MRI 8CH Tabletop for Siemens 1.5T

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility