Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004526608

FEI Number

3004526608

Entity Name

GE HEALTHCARE

City/State/Country

Chicago, IL, US

Establishment Address

500 W. Monroe Street, Chicago, IL 60661, US

Establishment Type(s)

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

K211312

PMA Number

N/A

All Registered Proprietary Names

Centricity AW Suite MR Contour DL Centricity Perinatal Digital Expert Access with Remote Scanning Centricity Radiology RA600, Centricity Cardiology CA 1000, and Digital Hardcopy Centricity Radiology RA600 / Centricity Cardiology CA1000 / DHC Centricity PACS IW Centricity Universal Viewer Centricity Cardio Imaging View Centricity PACS IW Centricity PACS Centricity PACS (RA1000) Centricity PACS (RA1000) 4.x Centricity PACS (RA1000) 6.x Centricity PACS 6.x Centricity PACS 4.x Centricity PACS (RA1000)7.x Centricity PACS 7.x Centricity Universal Viewer 6.x Centricity Universal Viewer Centricity Universal Viewer 7.x Centricity Universal Viewer Zero Footprint client Centricity Universal Viewer Zero Footprint PACS-IW with Universal Viewer Universal Viewer Universal Viewer 8

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2000-03-06
QKB	Radiological Image Processing Software For Radiation Therapy	Radiology	Class 2	892.2050	2025-04-15
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2012-11-21
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2012-11-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-12-13
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2023-12-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2000-03-06
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2012-11-13
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-05-27
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2012-02-24
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-04-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2009-03-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2012-11-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-11-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-01-10
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-01-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2012-11-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-07-09

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
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
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0034-2014	GE Healthcare It	2	Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity Cardio Imaging is intended to assist trained professionals in the viewing, analysis and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians and assistants. Centricity Cardio Imaging is not intended for use in the patient vicinity.
Z-0039-2025	GE Healthcare	2	GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a) 2089507-120; b) 2089507-129; c) 2089507-131; d) 2089507-135; e) 2089507-136; f) 2089507-140; g) 2089507-144; h) 2089507-145; i) 2089507-149; j) 2089507-153; k) 2089507-154; l) 2089507-155; m) 2089507-156; n) 2089507-157; o) K2037DAED; p) K2037DBED; q) K2037DED; r) K2037DJED; s) K2037DNED; t) K2042TTED; u) K2049DC; v) K2049DD; w) K2049DF; x) P2037DAED; y) P2037DBED; z) P2037DED; aa) To be provided
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2

Similar Registrations

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3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3036758981	TAEYOUNG SOFT	Gwacheon-si Gyeonggi, KR
3010956703	Visual Medica	Ciudad Autonoma Buenos Aires Buenos Aires, Ciudad Autonoma de, AR
3030088963	REBRAIN	PESSAC Gironde, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004526608. Last updated year: 2026. Please use registration number 3004526608 when referencing this establishment in official correspondence.