Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617766

FEI Number

3002874382

Entity Name

GE BE PRIVATE LIMITED

City/State/Country

WHITEFIELD, BANGALORE Karnataka, IN

Establishment Address

60, EXPORT PROMOTION INDUSTRIAL PARK, WHITEFIELD, BANGALORE Karnataka 560 066, IN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,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

N/A

PMA Number

N/A

All Registered Proprietary Names

Jedi TTH Jedi80RF1T Jedi80R1T Jedi 80 RD 1T Jedi42CT Jedi 50 Plus R1T ZEUS Zyx Jedi 80 RF 1T Jedi50R1T JEDI 80 RF1T Jedi 50 R 1T Jedi NP+V1.5 TTH MAESTRO TTH HAWKEYE DMR JEDI 60 DC Jedi 60 DC Djinn Mammo Jedi80RF2T Prisme Jedi 42 CT JEDI SC FAST kV DJINN BEETLE VMX MPPU JEDI HP JEDI 100 VASC 1T CT MINI Jedi60CT X-Ray Generator ZJ/QJ Prodigy/DPX Series High Voltage Power Supply Jedi 60 DC LITE SYJ MPG50 JEDI 60 DC LITE Jedi 60DC Lite MPG100 VAMP Jedi 80 RF 2T JEDI VCT Jedi 80 R 1T TTH 8800 ZEUS, ZJ/QJ Jedi 100 VASC 1 BONZAI Djinn Beetle Jedi 60 CT Jedi 60DC GAIA INTERVENTIONAL GENERATOR Djinn Tonix Performix Plus LU43318ST LU8548STR Performix 40 Plus MAXIRAY 100 TH-M1 APOLLON Solarix 350 Brightspeed Performix HD 43318 45645 Performix Pulsar Performix VCT Plus Performix 40 LU45649ST LU45645STR Vamana Surgery MX100 FL MX135CT TH1.1 Maxiray MX100 FL Maxiray CT VCT MX200CT/Performix Ultra 5855555 LU45645 SB-80-200R Performix 160A LU8743STR Ergo MONOBLOCK Performix Pro VCT 100 LU45649 Maxiray MX100 RAD LU45649STR LU45645ST LU40782 Brivo OEC 2.2A X-ray Generator MX100 RAD LU8743ST Vamana RAD LU8548ST 40782 Performix HD Plus Artemis MX165 NP Quantix 160 Maxiray CT Ultra Performix HDw

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	Class 1	892.1700	2004-09-24
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	1999-10-06

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
9710090	GE ULTRASOUND KOREA, LTD.	Seongnam-Si Gyeonggi, KR
1651104	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES	EL PASO, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K950291	Fischer Imaging Corp.	DIGITAL 625HF	1995-03-23

Similar Registrations

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3007603422	Althea US, Inc.	Goodlettsville, TN, US
3000126629	Philips Electronics Ltd	Mississauga Ontario, CA
3003768251	Philips Medical Systems DMC GmbH	HAMBURG, DE
1450503	SUMMIT INDUSTRIES, LLC	Niles, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617766. Last updated year: 2026. Please use registration number 9617766 when referencing this establishment in official correspondence.