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Data / Medical devices / India / WIPRO GE HEALTHCARE PRIVATE Ltd.

WIPRO GE HEALTHCARE PRIVATE Ltd.: FDA-registered device maker in BANGALORE Karnataka, India, 43 510(k) clearances

WIPRO GE HEALTHCARE PRIVATE Ltd. is registered with the FDA (registration 3007734888) in BANGALORE Karnataka, India. It lists 28 device types. The FDA files 43 510(k) clearances under its listings, the newest dated August 10, 2026. 3 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch WIPRO GE HEALTHCARE PRIVATE Ltd.
FDA registration number
3007734888
Address
122 (Part 1), JOHN F. WELCH TECHNOLOGY CENTRE, ODYSSEY AND GALILEO EXPORT PROMOTIONAL INDUSTRIAL PARK, WHITEFIELD, BANGALORE Karnataka, India, 560066
Owner or operator
GE HealthCare Technologies Inc. (9912004)
Roles
Specification developer
First device listed
November 5, 1992
Registered through
2027
Brand names listed
AMX Navigate, AMX Navigate UPGRADE, BiliSoft, BiliSoft 2 Phototherapy System, BiliSoft LED Phototherapy System, BiliSoft Phototherapy System, Blue Spot PT, Blue Spot PT Lite and more

Devices it lists

DeviceProduct codeClassRoleSource
Automated Radiological Image Processing SoftwareQIH2Specification developeraccessdata.fda.gov
Binder, AbdominalFSD1Specification developeraccessdata.fda.gov
Computer, Diagnostic, ProgrammableDQK2Specification developeraccessdata.fda.gov
Detector And Alarm, ArrhythmiaDSI2Specification developeraccessdata.fda.gov
Display, Cathode-Ray Tube, MedicalDXJ2Specification developeraccessdata.fda.gov
ElectrocardiographDPS2Specification developeraccessdata.fda.gov
Electrode, ElectrocardiographDRX2Specification developeraccessdata.fda.gov
Incubator, NeonatalFMZ2Specification developeraccessdata.fda.gov
Instrument, Quality-Assurance, RadiologicLHO1Specification developeraccessdata.fda.gov
Mattress, Flotation Therapy, Non-PoweredIKY1Specification developeraccessdata.fda.gov
Monitor, Heart Rate, Fetal, UltrasonicHEL2Specification developeraccessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)MHX2Specification developeraccessdata.fda.gov
Monitor, Uterine Contraction, External (For Use In Clinic)HFM2Specification developeraccessdata.fda.gov
Radiological Computer Assisted Detection/Diagnosis Software For FractureQBS2Specification developeraccessdata.fda.gov
Radiological Computer-Assisted Prioritization Software For LesionsQFM2Specification developeraccessdata.fda.gov
Scale, PatientFRW1Specification developeraccessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)MQB2Specification developeraccessdata.fda.gov
Stand, InfusionFOX1Specification developeraccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Specification developeraccessdata.fda.gov
System, Monitoring, PerinatalHGM2Specification developeraccessdata.fda.gov
System, Nuclear Magnetic Resonance ImagingLNH2Specification developeraccessdata.fda.gov
System, X-Ray, MobileIZL2Specification developeraccessdata.fda.gov
Transmitters And Receivers, Electrocardiograph, TelephoneDXH2Specification developeraccessdata.fda.gov
Unit, Neonatal PhototherapyLBI2Specification developeraccessdata.fda.gov
Uterine Electromyographic MonitorOSP2Specification developeraccessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)BTM2Specification developeraccessdata.fda.gov
Ventilator, Emergency, Powered (Resuscitator)BTL2Specification developeraccessdata.fda.gov
Warmer, Infant RadiantFMT2Specification developeraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 10, 2026K254036Novii+ Wireless Patch SystemHGMSubstantially EquivalentDatex Ohmeda, Inc.accessdata.fda.gov
December 13, 2023K231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemDQKSubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
December 8, 2023K231964Novii+ Wireless Patch SystemHGMSubstantially EquivalentDatex Ohmedaaccessdata.fda.gov
October 27, 2023K232346Digital Expert Access with Remote ScanningLNHSubstantially EquivalentGE Healthcareaccessdata.fda.gov
May 25, 2023K223491Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care SuiteQBSSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
December 21, 2022K222586Mural Clinical ViewerMHXSubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
June 23, 2022K220732Mural Perinatal SurveillanceHGMSubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
March 2, 2022K213553Giraffe Incubator Carestation CS1FMZSubstantially EquivalentDatex Ohmeda, Inc.accessdata.fda.gov
March 2, 2022K213551Giraffe Omnibed Carestation CS1FMTSubstantially EquivalentDatex Ohmeda, Inc.accessdata.fda.gov
October 29, 2021K211161Critical Care Suite with Endotracheal Tube Positing AI algorithmQIHSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
April 28, 2021K210982AMX NavigateIZLSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
February 12, 2021K201628Panda iRes Warmer, Giraffe WarmerFMTSubstantially EquivalentGE Healthcareaccessdata.fda.gov
August 12, 2019K183182Critical Care SuiteQFMSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
September 6, 2018K182234Optima XR240amxIZLSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
January 12, 2018K173602Optima XR240amx, AutoGridIZLSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
November 15, 2016K162990Optima XR240amxIZLSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
September 15, 2016K162012CARESCAPE Central Station V2DXJSubstantially EquivalentGE Healthcareaccessdata.fda.gov
March 17, 2016K152814Giraffe OmniBed Carestation CS1FMZSubstantially EquivalentOhmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Companyaccessdata.fda.gov
December 31, 2015K152809Giraffe Incubator Carestation CS1FMZSubstantially EquivalentOhmeda Medical, A Division of Datex-Ohmeda, Inc.accessdata.fda.gov
March 24, 2015K150193Customer Remote Console (CRC)LLZSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
August 27, 2014K140862MONICA NOVII WIRELESS PATCH SYSTEMOSPSubstantially EquivalentMonica Healthcare, Ltd.accessdata.fda.gov
February 5, 2013K123309GIRAFFE AND PANDA WARMERSFMTSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
October 2, 2012K122267GIRAFFE AND PANDA WARMERSFMTSubstantially EquivalentOhmeda Medical, A Division of Datex-Ohmeda, Inc.accessdata.fda.gov
September 14, 2012K121625LULLABY TM WARMERFMTSubstantially EquivalentWipro GE Healthcare Private, Ltd.accessdata.fda.gov
June 8, 2012K120820GIRAFFE BLUE SPOT PT LITELBISubstantially EquivalentLumitex, Inc.accessdata.fda.gov
May 2, 2012K120168LULLABY LED PHOTTHERAPY SYSTEMLBISubstantially EquivalentWipro GE Healthcare Private, Ltd.accessdata.fda.gov
July 19, 2011K110556MINI TELEMETRY SYSTEMHGMSubstantially EquivalentWipro GE Healthcare Private, Ltd.accessdata.fda.gov
May 17, 2011K103765MAC 600 RESTING ECG ANALYSIS SYSTEMDPSSubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
April 29, 2011K110266MAC 5500 HD, MAC 3500DPSSubstantially EquivalentGe Medical Systems Information Technologies, Inc.accessdata.fda.gov
February 16, 2011K103678CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEMDQKSubstantially EquivalentGe Medical Systems Information Technologies GmbHaccessdata.fda.gov
July 21, 2010K101804GIRAFFE AND PANDA WARMERSFMTSubstantially EquivalentOhmeda Medical, A Division of Datex-Ohmeda, Inc.accessdata.fda.gov
July 21, 2010K101788GIRAFFE OMNIBEDFMZSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
July 21, 2010K101778GIRAFFE INCUBATORFMZSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
April 16, 2009K090697MODIFICATION TO: GIRAFFE AND PANDA WARMERFMTSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
December 20, 2007K072976MODEL 250CX SERIES MATERNAL/FETAL MONITORHGMSubstantially EquivalentGE Healthcareaccessdata.fda.gov
August 27, 2007K072157MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)FMTSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
July 11, 2007K070377GIRAFFE AND PANDA WARMERFMTSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
April 20, 2007K070247GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEMBTMSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
April 20, 2007K070210GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEMBTLSubstantially EquivalentOhmeda Medicalaccessdata.fda.gov
April 17, 2006K053568BILISOFT PHOTOTHERAPY SYSTEMLBISubstantially EquivalentLumitex, Inc.accessdata.fda.gov
February 2, 2000K993751COROMETRICS MODEL 173 FETAL MONITORHGMSubstantially EquivalentGe Medical Systems Information Technologiesaccessdata.fda.gov
September 1, 1999K991905COROMETRICS MODEL 171 AND 172 FETAL MONITORHGMSubstantially EquivalentGeneral Electric Medical Systems Information Technaccessdata.fda.gov
December 11, 1998K982651COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCERHELSubstantially EquivalentCorometrics Medical Systems, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
September 5, 202597646Class IIOngoingGE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tubeCarescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.accessdata.fda.gov
August 9, 202495216Class IIOngoingGE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant wGE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for laccessdata.fda.gov
December 26, 202393780Class IOngoingGE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g.accessdata.fda.gov

Compare with other makers

Updated August 10, 2026. 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.