Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007734888

FEI Number

3007734888

Entity Name

WIPRO GE HEALTHCARE PRIVATE Ltd.

City/State/Country

BANGALORE Karnataka, IN

Establishment Address

122 (Part 1), JOHN F. WELCH TECHNOLOGY CENTRE, ODYSSEY AND GALILEO, EXPORT PROMOTIONAL INDUSTRIAL PARK, WHITEFIELD, BANGALORE Karnataka 560066, IN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K103678

PMA Number

N/A

All Registered Proprietary Names

Coro 173 Corometrics 171 Corometrics 174 Corometrics 173 Corometrics 172 Optima XR240amx BiliSoft 2 Phototherapy System BiliSoft LED Phototherapy System BiliSoft BiliSoft Phototherapy System Novii Novii Wireless Patch System Novii Interface Novii Pod Giraffe OmniBed + Shuttle Giraffe Omnibed Giraffe Shuttle Optima XR240amx Giraffe Warmer Panda Freestanding Warmer Panda Wall Mount Warmer Panda Ires Warmer Disposable Infant Skin Temperature Probe Giraffe Panda Disposable Infant Skin Temperature Probe Panda Warmer IV Pole ROTATING IV POLE Rotating IV1 IV POLE ASSY 12 IN 12 Inch IV1 IV POLE ASSY 24 IN 24 Inch IV1 LULLABY IV POLE IV1 MAC 600 Resting ECG Analysis System MAC 600 IQST assembly Quality Care Suite 2 Mini Telemetry System Giraffe Stand-alone Infant Resuscitation System (T-piece) StAR Giraffe Stand-alone Infant Resuscitation System (T-piece, and Bag and Mask) Giraffe Warmer Panda Warmer Panda iRes Warmer Giraffe Stand-alone Infant Resuscitation System Optima XR240amx Giraffe Incubator Carestation CS1 Giraffe Incubator Carestation Giraffe Panda Disposable Infant Skin Temperature Probe Disposable Infant Skin Temperature Probe Critical Care Suite with Endotracheal Tube Positioning AI Algorithm Critical Care Suite 2 Optima XR220amx Optima XR200amx Critical Care Suite Corometrics 171 Coro 172 Corometrics 172 Corometrics 174 Coro 174 COROMETRICS 172 Monitor COROMETRICS 173 Monitor COROMETRICS 174 Monitor COROMETRICS 171 Monitor Coro 171 COROMETRICS 171 COROMETRICS 174 COROMETRICS 172 CASE V7 Cardiac Testing System CardioSoft V7 Cardiac Testing System Lullaby LED PT Lullaby LED Phototherapy System AMX Navigate AMX Navigate UPGRADE COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER Patient Scale Giraffe Scale Giraffe In-Bed Scale GS1 Panda EU In-Bed Scale PS EU1 Giraffe EU In-Bed Scale GS EU1 Panda In-Bed Scale PS1 Panda Scale Panda Warmer Giraffe Warmer Transducer Belt Giraffe Omnibed Carestation CS1 Lullaby Warmer StAR Giraffe Stand-alone Infant Resuscitation System (Bag and Mask) Giraffe and Panda Bag and Mask Resuscitation System Giraffe Stand-alone Infant Resuscitation System Panda Warmer Giraffe Warmer Giraffe Incubator + Shuttle Giraffe Shuttle Giraffe Incubator Giraffe Warmer Panda iRes Warmer Panda Warmer Mural Clinical Viewer MAC 3500 MAC 5500 HD MAC 5500 HD ECG ANALYSIS SYSTEM CAM HD CAM 14 CareIntellect Perinatal Mural Perinatal Surveillance Novii Patch Novii Wireless Patch System Novii Giraffe Incubator Carestation CS1 CARDIOSOFT WEB CardioSoft V6.71. Cardiac Testing System CS V6.71 Cardiac Testing System CARDIOSOFT RESTING ECG CS V6.6. Cardiac Testing System CASE CASE V6.6. Cardiac Testing System CARDIOSOFT EKG VIEWER CASE V6.71. Cardiac Testing System CARDIOSOFT CLIENT Cardiosoft V6.72 CASE V6.7 CS V6.71 CARDIOSOFT EXERCISE STRESS TEST CardioSoft V6.73 CS V6.6 Cardiac Testing System CARDIOSOFT SERVER CardioSoft V6.71 Cardiac Testing System CASE V6.6 Cardiac Testing System CASE V6.71 Cardiac Testing System CASE V6.73

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2010-08-04
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2018-02-09
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-02-09
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2018-07-30
OSP	Uterine Electromyographic Monitor	Obstetrics/Gynecology	Class 2	884.2720	2017-12-15
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2010-12-07
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2017-01-04
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2017-01-04
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2013-02-11
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2007-01-09
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2011-05-19
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2009-04-30
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2011-08-19
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2009-07-16
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2018-11-02
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-11-02
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2016-01-12
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2022-01-14
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2014-10-17
QFM	Radiological Computer-Assisted Prioritization Software For Lesions	Radiology	Class 2	892.2080	2019-10-08
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2003-02-06
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-12-20
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2012-05-22
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2021-06-03
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2021-06-03
HEL	Monitor, Heart Rate, Fetal, Ultrasonic	Obstetrics/Gynecology	Class 2	884.2660	2007-12-20
HFM	Monitor, Uterine Contraction, External (For Use In Clinic)	Obstetrics/Gynecology	Class 2	884.2720	2007-12-20
FRW	Scale, Patient	General Hospital	Class 1	880.2720	1992-11-05
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2010-12-07
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2022-12-02
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2022-03-04
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2022-03-04
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2013-01-07
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2010-07-28
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2012-11-07
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2010-12-07
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2010-07-28
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2023-01-17
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2011-05-11
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2011-05-11
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2011-05-11
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2022-07-13
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2017-12-15
FMZ	Incubator, Neonatal	General Hospital	Class 2	880.5400	2022-03-04
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2011-08-26

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
K771196	Hewlett-Packard Co.	MARKER GENERATOR MODULES - 21597A	1977-08-03
K813458	Cranbury Medical Labs, Inc.	FETASCAN 1000, 1000A OBSTETRICAL DATA	1982-01-28
K100420	Philips Medizin Systeme Boeblingen GmbH	PHILIPS OBTRACEVUE MODEL SW REV. G.00	2010-07-26
K173941	Philips Medizin Systeme Boeblingen GmbH	IntelliSpace Perinatal Rev.K.00	2018-09-10
K062137	Philips Medizin Systeme Boeblingen GmbH	MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30	2006-08-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-06	N/A	2	FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
Z-0036-06	N/A	2	FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)
Z-1470-2023	FUJIFILM Healthcare Americas Corporation	2	FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Z-3158-2024	FUJIFILM Healthcare Americas Corporation	2	The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Z-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007734888. Last updated year: 2026. Please use registration number 3007734888 when referencing this establishment in official correspondence.