Data / Medical devices / China / Ge Hangwei Medical Systems Co., Ltd.
Ge Hangwei Medical Systems Co., Ltd.: FDA-registered device maker in Beijing, China, 62 510(k) clearances
Ge Hangwei Medical Systems Co., Ltd. is registered with the FDA (registration 9613445) in Beijing, China. It lists 22 device types. The FDA files 62 510(k) clearances under its listings, the newest dated April 20, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 9613445
- FEI number
- 3002175190
- Address
- West Area of Building No.3, No.1 Yongchang North Road Beijing Economic and Technological Development Area, Beijing, China, 100176
- Owner or operator
- GE HealthCare Technologies Inc. (9912004)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 22, 1978
- Registered through
- 2027
- Brand names listed
- 3DXR, 40782, 43318, 45645, 5855555, APOLLON, Allia IGS 3, Allia IGS 5 and more
Devices it lists
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 20, 2026 | K252718 | Lunar Astra | KGI | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| March 23, 2026 | K253686 | True Definition DL | JAK | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| November 26, 2025 | K253269 | OEC One CFD | OXO | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| August 28, 2025 | K250788 | Definium Tempo Select | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| August 1, 2025 | K250941 | Revolution Vibe | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 12, 2025 | K251153 | Aurora | KPS | Substantially Equivalent | Ge Medical Systems Israel | accessdata.fda.gov |
| January 17, 2025 | K243605 | Aurora | KPS | Substantially Equivalent | Ge Medical Systems Israel, Functional Imaging | accessdata.fda.gov |
| December 27, 2024 | K240828 | OEC One ASD | OXO | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| October 1, 2024 | K242678 | Definium Pace Select ET | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| August 8, 2024 | K241665 | Omni Legend | KPS | Substantially Equivalent | Ge Medical Systems Israel, Functional Imaging | accessdata.fda.gov |
| April 11, 2024 | K233698 | True Enhance DL | JAK | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| April 2, 2024 | K233750 | ECG-less Cardiac | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| February 22, 2024 | K233749 | Revolution Ascend Sliding | JAK | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| September 12, 2023 | K231892 | Definium Pace Select | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| April 27, 2023 | K223212 | Precision DL | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 1, 2023 | K221680 | Xeleris V Processing and Review System | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 2, 2022 | K221932 | Omni Legend | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| February 18, 2022 | K213999 | Deep Learning Image Reconstruction | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| February 4, 2022 | K213938 | Revolution Ascend | JAK | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| December 17, 2021 | K213715 | Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 20, 2021 | K211846 | Discovery MI Gen2 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 2, 2021 | K203617 | MaxFOV 2 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| December 10, 2020 | K201745 | Deep Learning Image Reconstruction for Gemstone Spectral Imaging | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 20, 2020 | K203169 | Revolution Ascend | JAK | Substantially Equivalent | Ge Healthcare Japan Corporation | accessdata.fda.gov |
| January 16, 2020 | K192956 | Auto Positioning | JAK | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| October 24, 2019 | K192686 | Revolution Maxima, Revolution Ace | JAK | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| July 26, 2019 | K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| July 24, 2019 | K191699 | Discovery XR656 HD with VolumeRad | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| April 12, 2019 | K183202 | Deep Learning Image Reconstruction | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 16, 2018 | K182626 | OEC One | OXO | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| November 2, 2018 | K181403 | Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR | OWB | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| April 17, 2018 | K173816 | NM/CT 850, NM/CT 860 | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| December 11, 2017 | K173612 | Optima XR646 HD | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| November 9, 2017 | K172700 | OEC One | OWB | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| October 20, 2017 | K172869 | Discovery XR656 HD | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| July 12, 2017 | K171800 | OEC Elite MiniView | OXO | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| June 5, 2017 | K171013 | Revolution ACT | JAK | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| June 21, 2016 | K160131 | OEC Elite MiniView | OXO | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| March 16, 2016 | K153355 | Xeleris 4.0 Processing and Review Workstation | LLZ | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 9, 2016 | K153429 | SmartView 3D Option | JAK | Substantially Equivalent | Ge Hangwei Medical System Co., Ltd. | accessdata.fda.gov |
| August 14, 2015 | K151372 | Low Dose CT Lung Cancer Screening Option for Qualified GE Systems | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| February 18, 2015 | K143270 | Optima XR646 | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| January 17, 2014 | K132410 | DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 18, 2013 | K132261 | DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) | IZF | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 30, 2013 | K131576 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| May 17, 2013 | K123603 | OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME | OXO | Substantially Equivalent | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | accessdata.fda.gov |
| April 12, 2013 | K130884 | XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION | LLZ | Substantially Equivalent | Ge Medical Systems F.I. Haifa | accessdata.fda.gov |
| February 8, 2013 | K123596 | OPTIMA CT520 | JAK | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| January 2, 2013 | K122457 | GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS | OWB | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 12, 2012 | K120833 | DISCOVERY CT750 HD | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| December 5, 2011 | K113350 | BRIVO NM 615 | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 12, 2011 | K103448 | BRIVO XR385 | KPR | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| July 20, 2011 | K110227 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 16, 2011 | K103476 | BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX | IZL | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 3, 2011 | K111445 | DISCOVERY NM 630 | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| April 19, 2011 | K093581 | DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 18, 2010 | K102615 | WIRELESS DR IMAGING OPTION-WDR1 | MQB | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| December 10, 2009 | K093514 | DISCOVERY MODEL NM/CT 670 | KPS | Substantially Equivalent | Ge Medical Systems F.I. Haifa | accessdata.fda.gov |
| October 17, 2008 | K082960 | GE XTREME INJECTOR OPTION | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 8, 2008 | K082816 | GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 9, 2005 | K051967 | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS | KPR | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| October 1, 1999 | K993090 | SILHOUETTE FC | KPR | Substantially Equivalent | Ge Medical Systems, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 7, 2023 | 93479 | Class II | Ongoing | The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors v | GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of elements of the Overhead Tube Suspension (OTS) assembly. | accessdata.fda.gov |
| September 18, 2013 | 66341 | Class II | Terminated | GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and | GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high voltage cable bundle to fail, resulting in loss of system functionality. | accessdata.fda.gov |
Compare with other makers
- All makers of Image-Intensified Fluoroscopic X-Ray System, Mobile
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Automated Radiological Image Processing Software
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of System, X-Ray, Stationary
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
Updated April 20, 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.