Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613936

FEI Number

1000571342

Entity Name

WIPRO GE HEALTHCARE PRIVATE LTD

City/State/Country

WHITEFIELD, BANGALORE Karnataka, IN

Establishment Address

122, Part I, EXPORT PROMOTIONAL INDUSTRIAL PARK, WHITEFIELD, BANGALORE Karnataka 560 066, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GE HealthCare Technologies Inc. (Owner Number: 9912004)

Owner / Operator Contact Address

3000 N. Grandview Blvd, Waukesha, WI 53188, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K142361

PMA Number

N/A

All Registered Proprietary Names

SIGNA Explorer SIGNA Creator SIGNA Explorer Quantum SIGNA MR355 SIGNA MR360 Optima MR450w GEM XP Gradient Optima MR450w GEM Optima MR450w 1.5T 8Ch GEM Breast Coil liberty 9000 8-ch breast coil with disposable biopsy plate 1.5T HD Breast Array Lateral Large Grid Biopsy Plate Medial Large Grid Breast Biopsy Plate 1.5T HD Flat GEM Table Breast Array Discovery MR750 3T DISCOVERY MR 750- 3T SPLIT HEAD COIL Discovery MR750 System GP Flex Coil 1T. GP Flex Coil 1.5T Discovery MR750w 3T Discovery MR750W MR 750W 3T GEM PA (Aurora only) 3T GEM HNU (Aurora only) 3T GEM PVA (Aurora only) 3T GEM Anterior Array (Aurora only) 1.5T SPLIT HEAD COIL 3T SPLIT HEAD COIL 3T GE Signa Excite HD MR System 1.5T GE Signa Excite HD MR System 1.5T Signa HD premier 9000 8 channel phased array 1.5T, 8Ch CTL coil-HDx CTL 8 Channel CTL Coil Signa HD 1.5T 8-Ch CTL Coil 1.5T HD 8 CH CTL Coil 1.5T 8 CH CTL Coil 3T SPLIT HEAD COIL Signa Excite 1.5T Expert. 1.5T SPLIT HEAD COIL SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY 5" ROUND COIL 1.5T 3" ROUND COIL 1.5T 3T SIGNA HDxt Mobile 3T SPLIT HEAD COIL 1.5T SPLIT HEAD COIL SIGNA VIBRANT 3T SIGNA HDXt 1.5T SIGNA HDXt 1.5T Signa HDxt Mobile 1.5T 4CH Large Flex Coil 1.5T 4CH Small Flex Coil 9E Express AA coil 16CH Express HNA coil 8ch Express PA coil 1.5T EXPRESS COIL - 16E HEAD NECK ARRAY 1.5T EXPRESS COIL - 9E ANTERIOR ARRAY DISCOVERY MR 450-1.5T SPLIT HEAD COIL Discovery MR450 3T HD Breast Array 3T 8Ch GEM Breast Coil 3T HD FLAT GEM Table Breast Array 1.5T SPLIT HEAD COIL GE 1.5T SIGNA HDE MR SYSTEM 8ch Express Suite Optima MR360 Brivo MR355 EXPRESS COIL - HEAD NECK ARRAY EXPRESS COIL - ANTERIOR ARRAY EXPRESS COIL - POSTERIOR ARRAY 1.5T, 4 CH. CTL SPINE COIL, Premier 7000 CTL Spine coil Signa HD 1.5T CTL Spine Coil PHASED ARRAY-HDe 1.5T 4 Ch. Premier 7000 CTL Coil Signa HDe 1.5T 4CH CTL Spine Coil Discovery MR750 3T 3T SPLIT HEAD COIL

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	2015-02-11
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2012-01-16
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2010-07-16
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2010-07-15
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2010-07-22
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2011-11-03
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2011-11-03
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2011-11-03
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2005-08-23
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2010-07-16
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2010-07-16
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2012-11-07
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2012-11-07
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2012-11-07
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2013-03-05
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2013-02-05
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2010-07-15
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2010-07-16
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2007-11-01
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2011-02-21
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2011-02-21
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2010-07-16
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2015-01-15

Official Correspondent

No official correspondent registered.

US Agent Details

Tracey Holevas Business: GE HealthCare Technologies, Inc Email: tracey.holevas@gehealthcare.com Phone: (262) 3092157

Related Public Records

Same Entity

GE HealthCare Technologies Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3015060224	IMACTIS, SAS	SAINT MARTIN D'HERES, FR
2122726	GE MEDICAL SYSTEMS, LLC	Milwaukee, WI, US
9617766	GE BE PRIVATE LIMITED	WHITEFIELD, BANGALORE Karnataka, IN
9710090	GE ULTRASOUND KOREA, LTD.	Seongnam-Si Gyeonggi, KR

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 9613936. Last updated year: 2026. Please use registration number 9613936 when referencing this establishment in official correspondence.