Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2122726

FEI Number

1000116747

Entity Name

GE MEDICAL SYSTEMS, LLC

City/State/Country

Milwaukee, WI, US

Establishment Address

4855 West Electric Avenue, Milwaukee, WI 53219, US

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

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
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	1999-10-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
9617766	GE BE PRIVATE LIMITED	WHITEFIELD, BANGALORE Karnataka, IN
9710090	GE ULTRASOUND KOREA, LTD.	Seongnam-Si Gyeonggi, KR
1651104	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES	EL PASO, TX, US

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3006789424	Hangzhou Kailong Medical Instruments Co., Ltd.	Hangzhou Zhejiang, CN
3000275399	Siemens Healthineers AG	RUDOLSTADT Thuringia, DE
3017616637	MINGWEI MEDICAL TECHNOLOGY(SUZHOU) CO.,LTD	Suzhou Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2122726. Last updated year: 2026. Please use registration number 2122726 when referencing this establishment in official correspondence.