BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Lateral Array Coil Right VS 8Ch

    Reg #: 3000126629 · FEI: 3000126629 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    70
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Philips Electronics Ltd
    Registration Number
    3000126629
    FEI Number
    3000126629
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1875 Buckhorn Gate, 5th Floor
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K100113

    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
    Shaylee Masilunas
    Address
    6501 Living Place
    City
    Pittsburgh
    State
    PA
    ZIP
    15206
    Country
    US
    Email
    [email protected]
    Phone
    724 8162019

    Products

    Device Name Product Code
    Coil, Magnetic Resonance, Specialty MOS

    Proprietary Names

    Lateral Array Coil Right VS 8Ch Sentinelle Breast MRI 8CH Tabletop 1.5T Lateral Array Coil Left VG STR VS BRST 1.5T 8CH TT FULL SET w TIM4G RSR Lateral Array Coil VG BRST TABLE 1.5T 16CH GE450 FULSET GRD Lateral Array Coil Left VG BREAST 1.5T 16CH GE450 FUL SET w GRID Vanguard Atlas/Titan Lateral Array Coil Right Vanguard Breast MRI Tabletop Coil Lateral Array Coil Right VG STR VS BRST 3T 4CH TT BIOPSY SET w PACKAGING SENTINELLE BREAST MRI 8CH Table for GE 3T VT1.5T 8CH TT TITAN FULL SET w GRID Medial Array Coil VS Cable Tray HYP VG ST Medial Single Loop Coil Left VG STR VS BRST 3T 8CH TT FULL SET w ESPREE RSR VS BRST 1.5T 8CH TT FUL SET w ESPREE RSR Vanguard Breast MRI Auxiliary Table with 16 Channel Coil Array for GE 3T MRI System Model 4000451-51 Lateral Single Loop Coil Right VG GE750 Lateral Array Coil Left VG GE750 Lateral Array Coil Right VT Lateral Array Coil Left VG GE450 Lateral Array Coil Right VGTT Single Loop Coil Left VT Lateral Array Coil Left VGTT Lateral Single Loop Coil Left VGTT Vanguard Breast MRI Table Interface Box VT Medial Plug VGTT Lateral Array Coil Right VG GE750 Lateral Single Loop Coil Left VG GE750 Interface Box VG GE750 Lateral Array Coil Right VG GE450 Interface Box VGTT 8Ch Cable Tray VG GE450 Lateral Single Loop Coil Right VGTT Lateral Single Loop Coil Left VG GE450 Medial Array Coil VG GE750 Lateral Single Loop Coil Right VG GE450 Medial Array Coil VGTT Medial Array Coil VT Single Loop Coil Right VT Medial Plug VT Medial Array Coil VG GE450 Medial Plug VG GE450 Lateral Array Coil Left VT Medial Plug VG GE750 SENTINELLE BREAST MRI 8CH Tabletop 3T Medial Array Coil VS 8Ch SENTINELLE BREAST MRI 16CH Tabletop for GE 3T Medial Single Loop Coil Right VG STR Sentinelle Breast MRI 8CH Table for GE 1.5T Sentinelle Breast MRI 8CH Tabletop for Siemens 1.5T Lateral Single Loop Coil Left VG STR SENTINELLE BREAST MRI 8CH Tabletop for SIEMENS 3T Coil Lateral 8CH Array Left VT 3T Medial Array Coil VG STR Lateral Array Coil Left VS 8Ch SENTINELLE BREAST MRI 16CH Table for GE 1.5T Medial Plug VG STR VS BRST 3T TT UPGRADE BIOPSY SET w PACKG VS BRST 3T 8CH TT FULL SET w TIM4G RSR VS BRST 1.5T 8CH TT FUL SET w SHALOW RSR Lateral Single Loop Coil Right VG STR VS BRST 3T 8CH TT FULL SET w SHALLOW RSR Coil Medial Array VT 3T VS BREAST 3T 8CH TT FULL SET w PACKAGING

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device