FDA.reportPublic FDA data

WIPRO GE HEALTHCARE PRIVATE LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96139361000571342WIPRO GE HEALTHCARE PRIVATE LTD1N2026-01-01122, Part I, EXPORT PROMOTIONAL INDUSTRIAL PARK WHITEFIELD, BANGALORE Karnataka IN 560 066

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
266041686591810K980157PREMIER 7000 CTL SPINE COILMOS1998-04-13
266041808495795K923264GENERAL PURPOSE FLEX COILLNH1992-09-30
266041155765179K173816NM/CT 850, NM/CT 860KPS2018-04-17
266041515240807K143251SIGNA Creator, SIGNA ExplorerLNH2015-02-04
266041361345260K142361Discovery MR750 3.0TLNH2014-12-05
266041321244866K142085DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5TLNH2014-09-26
266041831643512K141477DISCOVERY IQKPS2014-09-18
266041199830746K1236811.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COILMOS2013-02-22
266041467218663K123417BRIVO MR355, OPTIMA MR360LNH2013-01-17
266041510863412K1216761.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANTLNH2012-09-20
266041196014947K113490OPTIMA MR450WLNH2012-01-13
266041344036197K103330BRIVO MR355, OPTIMA MR360LNH2011-02-11
266041559491203K103327DISCOVERY MR750W 3.0TLNH2011-09-30
266041384819507K091536OPTIMA MR450WLNH2009-07-17
266041699168798K083147DISCOVERY MR450LNH2008-11-04
266041286127436K081028SIGNA 3.0T MR750 SYSTEMLNH2008-04-25
266041509203389K052978GE 1.5T SIGNA HDE MR SYSTEMLNH2005-11-09
266041246033859K0525853T HD BREAST ARRAYMOS2005-10-04
266041144134277K052293GE 1.5T AND 3.0T SIGNA HDX MR SYSTEMLNH2005-09-21
266041609665491K041695LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATELNH2004-07-23
266041850564884K041476GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEMLNH2004-06-17
266041353737708K032795GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEMLNH2003-10-08
266041097045036K031366PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COILMOS2003-07-11
266041327814682K030953GE 3.0T GENERAL PURPOSE FLEX COILMOS2003-04-10
266041246476584K022960GE QUASAR NUCLEAR MEDICINE SYSTEMKPS2002-09-19
266041848977563K013636SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGYLNH2002-01-24
266041712242455
266041713693862

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LNH182015-02-04
MOS52013-02-22
KPS32018-04-17