BEUDAMED
    FDA Registration Active 🇮🇳 India

    Philips India Limited - Magnetic Resonance Business Unit

    Reg #: 3033527281 · FEI: 3033527281 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    101
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    Philips India Limited - Magnetic Resonance Business Unit
    Registration Number
    3033527281
    FEI Number
    3033527281
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Philips Innovation Campus, Embassy Business Hub, Venkatala Village, Yelahanka Hobli, Yelahanka
    City
    Bengaluru Karnataka
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K110151

    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 MEDICAL SYSTEMS INTERNATIONAL BV
    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
    System, Nuclear Magnetic Resonance Imaging LNH
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    System, Planning, Radiation Therapy Treatment MUJ
    Set, I.V. Fluid Transfer LHI

    Proprietary Names

    Ingenia 1.5T Ingenia 3T Ingenia CX 3T Achieva R4 1.5T (Ingenia) Achieva R4 3T (ingenia) Ingenia CX 1.5T wBTS wPPU Sensor Accessories - 98980319363X wBTS Sensor Set, ECG 1 meter - 98980319364X wBTU PPU + RESP Module - 98980319445X wBTU VCG Module - 98980319444X MICROSCOPY COIL SET, INGENIA 3T dS MICROSCOPY 23MM COIL, INGENIA 3T dS MICROSCOPY 47MM COIL, INGENIA 3T dS MICROSCOPY 47MM COIL, INGENIA 1.5T MICROSCOPY COIL SET, INGENIA 1.5T dS MICROSCOPY 23MM COIL, INGENIA 1.5T SYN.BODY COIL 1.5T ODU 4598-005-5189x SENSE FLEX S COIL 1.5T ODU 4522-133-1719x T/R Head Coil 1.5T (QHC 1H T/R ACS-NT-L) 4598-002-0529x QUAD HEAD COIL 1.5T 4522-133-1727x SENSE FLEX L COIL 1.5T ODU 4522-133-1715x MRI COILS SYN.BODY COIL 1.5T WITH SLEEVE 4598-000-5187x SENSE SPINE COIL 1.5T ODU 4522-133-1724x SYN.BODY COIL 1.5T ODU WITH SLEEVE 4598-009-6978x SENSE CARDIAC COIL 4522-133-1726x SENSE FLEX M COIL 1.5T ODU 4522-133-1717x SENSE SPINE COIL 1.5T 4522-133-1723x SHNC DRIVERBOX 1.5T 4598-000-5181x SHNC DRIVERBOX 1.5T ODU 4598-000-5182x Achieva 1.5T family Intera 1.5T family SENSE FLEX S COIL 1.5T 4522-133-1718x CIRC.COIL C3 1.5T 4598-000-5196x MICRO 23MM COIL 4598-000-5197x MICRO 47MM COIL 4598-000-5198x ANTERIOR - SYN HEAD/NECK COIL 4598-000-5192x POSTERIOR - SYN HEAD/NECK COIL 4598-000-5193x CIRC.COIL C1 1.5T 4598-000-5184x SENSE CARDIAC COIL 4522-133-1725x SENSE FLEX M COIL 1.5T 4522-133-1716x SENSE FLEX L COIL 1.5T 4522-133-1714x Ingenia Elition MR 7700 with Distributed Multi Nuclei Ingenia 3TCX Ingenia Elition S Ingenia Elition X Achieva Family T/R HEAD COIL 3T 4598-001-5223x SENSE FLEX L COIL 3T ODU 4522-133-1722x SENSE FLEX M COIL 3T ODU 4522-133-1721x SENSE FLEX S COIL 3T ODU 4522-133-1720x Panorama 1T Panorama HFO Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems BlueSeal SE BlueSeal XE MRCAT Brain / RTgo 4 Ingenia 1.5T S Ingenia Ambition X Ingenia 3T CX Ingenia 1.5T CX Ingenia Ambition S Achieva, Intera,&Panaroma 1T R2 Intera Achieva Intera Sensation Family Intera I/T MR system Achieva 1.5T, 3T, and Intera 1.5T Sense head coil 3T Sense NV Coil 3T MR 7700 Upgrade to MR 7700 SmartPath to Ingenia Elition X SmartPath to MR 7700 Evolution Upgrade 1.5T Upgrades dStream to R12 SmartPath to dStream for 1.5T Evolution Upgrade 3T MR 5300 SmartPath to dStream for 3T Ingenia Elition X R5.4 Ingenia Ingneia CX Ingenia Ambition INgenia 1.5T, Ingenia 1.5T S and Ingenia 3T R5.3 BlueSeal QE Upgrades dStream to R13 Ingenia Elition R5.7.1 SP4 MR Systems Ingenia 1.5T S - 781-347 Ingenia 1.5T - 781-341 INgenia 1.5T CX and Ingenia 3T CX R5.3 MR-RT CouchTop MRCAT Head & Neck/RTgo 5 RT couchTop XD MR 5300 and MR 7700 R11 MR Systems MRCAT Pelvis / RTgo 3 Philips MRCAT RTgo Ingenia 3T CX R5.4 Ingenia Elition and MR 7700 MR Systems

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device