Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033527281

FEI Number

3033527281

Entity Name

Philips India Limited - Magnetic Resonance Business Unit

City/State/Country

Bengaluru Karnataka, IN

Establishment Address

Philips Innovation Campus, Embassy Business Hub, Venkatala Village, Yelahanka Hobli, Yelahanka, Bengaluru Karnataka 560064, IN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Philips Medical Systems International BV (Owner Number: 1217116)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232030

PMA Number

N/A

All Registered 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 3T 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 Ingenia 1.5T S Ingenia Ambition X Ingenia 3T CX Ingenia Elition X Ingenia 3T Ingenia 1.5T CX Ingenia Ambition S Ingenia Elition S Achieva, Intera,&Panaroma 1T R2 Intera Achieva Panorama 1T 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 BlueSeal SE SmartPath to MR 7700 Ingenia Ambition X Ingenia Elition X Evolution Upgrade 1.5T Upgrades dStream to R12 SmartPath to dStream for 1.5T Evolution Upgrade 3T BlueSeal XE Ingenia Elition S MR 5300 Ingenia Ambition S SmartPath to dStream for 3T Ingenia Elition X R5.4 Ingenia Elition S Achieva Ingenia Ingneia CX Ingenia Ambition Intera Ingenia Elition INgenia 1.5T, Ingenia 1.5T S and Ingenia 3T R5.3 MR 5300 Upgrade to MR 7700 Evolution Upgrade 1.5T SmartPath to MR 7700 SmartPath to Ingenia Elition X BlueSeal XE Ingenia Elition S BlueSeal QE Upgrades dStream to R13 Ingenia Elition X BlueSeal SE MR 7700 Evolution Upgrade 3T MR 5300 Ingenia Elition R5.7.1 SP4 MR Systems

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2011-03-23
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2009-05-15
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2022-03-04
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2022-03-04
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2018-03-22
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2018-03-22
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2009-05-15
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2009-05-15
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2023-04-14
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-04-14
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2022-04-20
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2019-02-19
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2019-02-19
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2009-05-15
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2008-11-12
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2009-05-15
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2009-05-15
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2019-06-12
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2019-06-12
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-06-16
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2025-06-16
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2018-03-07
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2018-03-07
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2020-04-14
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2020-04-14
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2017-01-09
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2017-01-09
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2021-11-22
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2021-11-22
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2026-03-19
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2026-03-19
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-08-10
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2023-08-10

Official Correspondent

No official correspondent registered.

US Agent Details

Maria Heiling Business: PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV Email: maria.heiling@philips.com Phone: (858) 2487651

Related Public Records

Same Entity

Philips Medical Systems International BV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

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3038281851	Philips Polska Sp. z o.o.	Lodz Lodzkie, PL
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3008514395	Telcare, LLC	Linwood, PA, US
3004961434	RESPIRATORY TECHNOLOGIES, INC.	Plymouth, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033504	General Electric Co.	GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM	2003-11-25
K013636	GE Medical Systems	SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY	2002-01-24
K250443	Siemens Healthcare GmbH	MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile	2025-06-16
K151015	Hitachi Medical Systems America, Inc.	ECHELON Oval V 5.0 MRI System	2015-07-29
K910715	Philips Medical Systems (Cleveland), Inc.	VISTA HPQ SYSTEM	1991-06-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2007	Hitachi Medical Systems America Inc	2	MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0033-2014	Philips Medical Systems (Cleveland) Inc	2	Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Z-0389-2024	Philips North America Llc	2	Achieva 1.5T
Z-0390-2024	Philips North America Llc	2	Achieva 1.5T Conversion
Z-0391-2024	Philips North America Llc	2	Achieva 1.5T Initial System

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033527281. Last updated year: 2026. Please use registration number 3033527281 when referencing this establishment in official correspondence.