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Wipro Ge Healthcare Private Ltd: FDA-registered device maker in WHITEFIELD, BANGALORE Karnataka, India, 23 510(k) clearances

Name: Wipro Ge Healthcare Private Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Wipro Ge Healthcare Private Ltd is registered with the FDA (registration 9613936) in WHITEFIELD, BANGALORE Karnataka, India. It lists 5 device types. The FDA files 23 510(k) clearances under its listings, the newest dated February 4, 2015. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 9613936
FEI number: 1000571342
Address: 122, Part I, EXPORT PROMOTIONAL INDUSTRIAL PARK, WHITEFIELD, BANGALORE Karnataka, India, 560 066
Owner or operator: GE HealthCare Technologies Inc. (9912004)
Roles: Manufacturer
First device listed: September 24, 2004
Registered through: 2027
Brand names listed: 1.5T 4 Ch. Premier 7000 CTL Coil, 1.5T 4CH Large Flex Coil, 1.5T 4CH Small Flex Coil, 1.5T 8 CH CTL Coil, 1.5T 8Ch GEM Breast Coil, 1.5T EXPRESS COIL - 16E HEAD NECK ARRAY, 1.5T EXPRESS COIL - 9E ANTERIOR ARRAY, 1.5T GE Signa Excite HD MR System and more

Devices it lists

Device	Product code	Class	Role	Source
Coil, Magnetic Resonance, Specialty	MOS	2	Manufacturer	accessdata.fda.gov
Generator, High-Voltage, X-Ray, Diagnostic	IZO	1	Manufacturer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Manufacturer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Spectroscopic	LNI	2	Manufacturer	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 4, 2015	K143251	SIGNA Creator, SIGNA Explorer	LNH	Substantially Equivalent	Ge Healthcare (Ge Medical Systems, LLC)	accessdata.fda.gov
December 5, 2014	K142361	Discovery MR750 3.0T	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
September 26, 2014	K142085	DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
September 18, 2014	K141477	DISCOVERY IQ	KPS	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
February 22, 2013	K123681	1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL	MOS	Substantially Equivalent	Wipro GE Healthcare Private, Ltd.	accessdata.fda.gov
January 17, 2013	K123417	BRIVO MR355, OPTIMA MR360	LNH	Substantially Equivalent	Ge Hangwei Medical Systems Co., Ltd.	accessdata.fda.gov
September 20, 2012	K121676	1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
January 13, 2012	K113490	OPTIMA MR450W	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
September 30, 2011	K103327	DISCOVERY MR750W 3.0T	LNH	Substantially Equivalent	Ge Healthcare Japan Corporation	accessdata.fda.gov
February 11, 2011	K103330	BRIVO MR355, OPTIMA MR360	LNH	Substantially Equivalent	Ge Hangwei Medical Systems Co., Ltd.	accessdata.fda.gov
July 17, 2009	K091536	OPTIMA MR450W	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
November 4, 2008	K083147	DISCOVERY MR450	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
April 25, 2008	K081028	SIGNA 3.0T MR750 SYSTEM	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
November 9, 2005	K052978	GE 1.5T SIGNA HDE MR SYSTEM	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
October 4, 2005	K052585	3T HD BREAST ARRAY	MOS	Substantially Equivalent	Usa Instruments, Inc.	accessdata.fda.gov
September 21, 2005	K052293	GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
July 23, 2004	K041695	LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE	LNH	Substantially Equivalent	Usa Instruments, Inc.	accessdata.fda.gov
June 17, 2004	K041476	GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM	LNH	Substantially Equivalent	Ge Medical Systems, LLC	accessdata.fda.gov
July 11, 2003	K031366	PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL	MOS	Substantially Equivalent	Usa Instruments, Inc.	accessdata.fda.gov
April 10, 2003	K030953	GE 3.0T GENERAL PURPOSE FLEX COIL	MOS	Substantially Equivalent	Ge Medical Systems, Inc.	accessdata.fda.gov
January 24, 2002	K013636	SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY	LNH	Substantially Equivalent	GE Medical Systems	accessdata.fda.gov
April 13, 1998	K980157	PREMIER 7000 CTL SPINE COIL	MOS	Substantially Equivalent	Usa Instruments, Inc.	accessdata.fda.gov
September 30, 1992	K923264	GENERAL PURPOSE FLEX COIL	LNH	Substantially Equivalent	General Electric Co.	accessdata.fda.gov

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Updated February 4, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.