BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    SHNC DRIVERBOX 1.5T ODU 4598-000-5182x

    Reg #: 3000126629 · FEI: 3000126629 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    26
    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
    K052013

    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
    System, Nuclear Magnetic Resonance Imaging LNH

    Proprietary Names

    SHNC DRIVERBOX 1.5T ODU 4598-000-5182x SYN.BODY COIL 1.5T ODU 4598-005-5189x Intera 1.5T family SENSE FLEX S COIL 1.5T ODU 4522-133-1719x QUAD HEAD COIL 1.5T 4522-133-1727x MRI COILS SENSE SPINE COIL 1.5T 4522-133-1723x SENSE SPINE COIL 1.5T ODU 4522-133-1724x SENSE CARDIAC COIL 4522-133-1726x SYN.BODY COIL 1.5T WITH SLEEVE 4598-000-5187x SENSE FLEX L COIL 1.5T ODU 4522-133-1715x SHNC DRIVERBOX 1.5T 4598-000-5181x SYN.BODY COIL 1.5T ODU WITH SLEEVE 4598-009-6978x SENSE FLEX M COIL 1.5T ODU 4522-133-1717x T/R Head Coil 1.5T (QHC 1H T/R ACS-NT-L) 4598-002-0529x Achieva 1.5T family CIRC.COIL C3 1.5T 4598-000-5196x ANTERIOR - SYN HEAD/NECK COIL 4598-000-5192x POSTERIOR - SYN HEAD/NECK COIL 4598-000-5193x MICRO 47MM COIL 4598-000-5198x SENSE FLEX S COIL 1.5T 4522-133-1718x SENSE FLEX L COIL 1.5T 4522-133-1714x SENSE CARDIAC COIL 4522-133-1725x MICRO 23MM COIL 4598-000-5197x SENSE FLEX M COIL 1.5T 4522-133-1716x CIRC.COIL C1 1.5T 4598-000-5184x

    Establishment Types

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