GE Hangwei Medical Systems Co., Ltd.
Manufacturer and brand owner in Beijing, China. 22 device types, 10 products catalogued, 10 clearances.
GE Hangwei Medical Systems Co., Ltd. is a specification developer holding a current FDA establishment registration. The registration covers Densitometer, Bone, System, X-Ray, Mobile and 20 other device types. 10 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 1978.
22device types registered with the FDA
10products catalogued under its own name
10510(k) clearances
3recalls
Registration
| Registered name | GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 9613445 |
| FEI number | 3002175190 |
| DUNS | 554408642 |
| Establishment type | Specification developer, Manufacturer |
Chinese Registration
| Chinese legal name | 航卫通用电气医疗系统有限公司 |
|---|---|
| Unified social credit code | 911103026000081377 |
| Source | export sales certificate, Beijing medical products administration |
Location
| City | Beijing |
|---|---|
| Province | Beijing |
| Address | West Area of Building No.3, No.1 Yongchang North Road |
| Postal code | 100176 |
| Country | China |
Group
GE Hangwei Medical Systems Co., Ltd. is one of 5 plants registered under GE HealthCare Technologies Inc..
| Plant | City | Device types |
|---|---|---|
| GE Healthcare (China) Co., Ltd. | Beijing | 22 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | 57 |
| GE Healthcare (Tianjin) Company Limited | Tianjin | 5 |
| GE Healthcare (China) Co., Ltd. – Tianjin | Tianjin | 3 |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Assembly, Tube Housing, X-Ray, Diagnostic | Class 1 | LU45645STR, Solarix 350 Brightspeed, LU8548ST, Performix Pro VCT 100, Performix Plus, Performix VCT Plus and 40 more | 1999 | 13 |
| Automated Radiological Image Processing Software | Class 2 | OEC One CFD | 2025 | 8 |
| Bed, Scanning, Nuclear | Class 1 | NM/CT Patient Table, NM Patient Table | 1994 | 1 |
| Collimator, Automatic, Radiographic | Class 2 | LU50090, HELIOS Collimator, X-Ray Collimator, OEC Beam Limiting Device, Prodigy/DPX Series Collimator Assembly, Lunar iDXA series Collimator Assembly and 1 more | 2014 | 5 |
| Densitometer, Bone | Class 2 | Lunar Astra | 2026 | 1 |
| Holder, Radiographic Cassette, Wall-Mounted | Class 1 | Wallstand (GCMWS-C5), WALL MOUNTED CASSETTE HOLDER Wallstand for X-Ray System, Wallstand (Model: VMWS-1; VMWS-2), Wallstand (Model: GCEWS-C4), Wallstand (Model: GCWS-C3; GCWS-C5; GCWS-C6) | 1978 | 6 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | Class 2 | Discovery IGS 7 OR, Discovery IGS 7, IGS WF BP, Innova IGS 5, IGS WF SP, 3DXR and 22 more | 2013 | 3 |
| Instrument, Quality-Assurance, Radiologic | Class 1 | IQST assembly, Quality Care Suite 2 | 2009 | 3 |
| Interventional Fluoroscopic X-Ray System | Class 2 | Discovery IGS 7 OR, Discovery IGS 7, IGS WF BP, Innova IGS 5, IGS WF SP, 3DXR and 27 more | 2013 | 5 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | Class 2 | Optima XR646, Wireless DR Imaging Option (WDR1), FlashPad, Definium Pace Select ET, Definium Tempo Select, Discovery XR650 and 11 more | 2010 | 13 |
| Support, Patient Position | Class 1 | Repressing Belt-Rohs, REPRESSING BELT-Standard table, Repression Belt (B2100BLT), Compression Band (Model: 5794807) | 2018 | 66 |
| System, Image Processing, Radiological | Class 2 | Xeleris 4 Processing and Review Workstation, Xeleris 4 DR Processing and Review Workstation, Xeleris V Processing and Review System, Xeleris 3.1, Volumetrix MI, Xeleris 3.1 Processing AND Review Workstation and 1 more | 2013 | 16 |
| System, Tomography, Computed, Emission | Class 2 | NM 830, Discovery NM 630, Max Elite, Omni Legend, Max Apollo, Discovery MI Gen2 and 16 more | 2010 | 4 |
| System, X-Ray, Angiographic | Class 2 | Discovery IGS 7 OR, Discovery IGS 7, IGS WF BP, Innova IGS 5, IGS WF SP, 3DXR and 24 more | 2013 | 7 |
| System, X-Ray, Fluoroscopic, Image-Intensified | Class 2 | Discovery IGS 7 OR, Discovery IGS 7, IGS WF BP, Innova IGS 5, IGS WF SP, 3DXR and 37 more | 2013 | 9 |
| System, X-Ray, Mobile | Class 2 | Collimator X-Ray, Collimator, Optima XR220amx, Brivo XR285amx, Optima XR200amx | 2011 | 5 |
| System, X-Ray, Stationary | Class 2 | Optima XR646, Definium Pace Select ET, Definium Tempo Select, Discovery XR650, Definium 8000, Discovery XR656 and 11 more | 2007 | 7 |
| System, X-Ray, Tomographic | Class 2 | Discovery XR650, Definium 8000, Discovery XR656, Optima XR640, Discovery XR656 with VolumeRAD, Discovery XR656 HD with VolumeRad and 6 more | 2010 | 2 |
| System, X-Ray, Tomography, Computed | Class 2 | Discovery CT, Revolution Frontier, Revolution Frontier ES, Discovery CT750 HD, Revolution HD, Revolution Frontier Gen 3_HD Refresh Package and 89 more | 2010 | 8 |
| Table, Radiographic, Non-Tilting, Powered | Class 2 | GCTBL-C4, Lite (LITE TABLE N9 ED3, Lite Table), VT1700 (GT1700 N9 ED3), VT2000 (GT2000 N9 ED3), GT1700V(GT1700V N9 ED3, GT1700V), VT1700V(GT1700V N9 ED3) and 18 more | 2004 | 3 |
| Table, Radiographic, Tilting | Class 2 | Table (Model: GCTBL-C44) | 2002 | 2 |
| Tube Mount, X-Ray, Diagnostic | Class 1 | OVERHEAD TUBE SUSPENSION (OTS for Definium Tempo Pro and Definium Tempo) (Model: 5822306), OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-9), OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-8), Tubestand (Model: GCTS-C11), OVERHEAD TUBE SUSPENSION (OTS) (Model: 5135678-10), OVERHEAD TUBE SUSPENSION (OTS for Definium Tempo Pro and Definium Tempo) (Model: 5822306-1) and 3 more | 1978 | 5 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Revolution | JAK | 20 |
| Optima | JAK | 6 |
| Table, Radiographic, Non-Tilting, Powered | IZZ | 3 |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 |
| RT | JAK | 1 |
| Discovery | JAK | 1 |
| Revolution Apex | JAK | 1 |
| Operator Console | JAK | 1 |
| System, X-Ray, Tomography, Computed | JAK | 1 |
| MaxFOV 2 | JAK | 1 |
Clearances
10 clearances name GE Hangwei Medical Systems Co., Ltd. as applicant. 55 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K233749 | 2024-02-22 | JAK | Special | This company |
| K192956 | 2020-01-16 | JAK | Traditional | This company |
| K192686 | 2019-10-24 | JAK | Special | This company |
| K171013 | 2017-06-05 | JAK | Traditional | This company |
| K160131 | 2016-06-21 | OXO | Traditional | This company |
| K123596 | 2013-02-08 | JAK | Traditional | This company |
| K123417 | 2013-01-17 | LNH | Traditional | This company |
| K122694 | 2012-10-25 | MOS | Traditional | This company |
| K120778 | 2012-03-27 | LNH | Special | This company |
| K103330 | 2011-02-11 | LNH | Traditional | This company |
| K252718 | 2026-04-20 | KGI | Traditional | GE Medical Systems Ultrasound & Primary Care Diagnostics LLC |
| K253686 | 2026-03-23 | JAK | Traditional | GE Healthcare Japan Corporation |
| K253269 | 2025-11-26 | OXO | Traditional | Ge Hualun Medical Systems Co., Ltd. |
| K250788 | 2025-08-28 | KPR | Traditional | Ge Hualun Medical Systems Co., Ltd. |
| K250941 | 2025-08-01 | JAK | Traditional | GE Medical Systems, LLC |
| K251153 | 2025-06-12 | KPS | Traditional | GE Medical Systems, Israel Ltd. |
| K243605 | 2025-01-17 | KPS | Traditional | GE Medical Systems Israel, Functional Imaging |
| K240828 | 2024-12-27 | OXO | Traditional | Ge Hualun Medical Systems Co., Ltd. |
| K242678 | 2024-10-01 | KPR | Special | Ge Hualun Medical Systems Co., Ltd. |
| K241665 | 2024-08-08 | KPS | Traditional | GE Medical Systems Israel, Functional Imaging |
| K233698 | 2024-04-11 | JAK | Traditional | GE Healthcare Japan Corporation |
| K231892 | 2023-09-12 | KPR | Traditional | Ge Hualun Medical Systems Co., Ltd. |
| K223212 | 2023-04-27 | KPS | Traditional | GE Healthcare GmbH |
| K221680 | 2023-03-01 | LLZ | Traditional | GE Healthcare GmbH |
| K221932 | 2022-09-02 | KPS | Traditional | GE Healthcare GmbH |
| K213999 | 2022-02-18 | JAK | Traditional | GE Medical Systems, LLC |
| K213938 | 2022-02-04 | JAK | Traditional | GE Healthcare Japan Corporation |
| K213715 | 2021-12-17 | JAK | Special | GE Medical Systems, LLC |
| K211846 | 2021-08-20 | KPS | Traditional | GE Medical Systems, LLC |
| K203617 | 2021-03-02 | JAK | Traditional | GE Medical Systems, LLC |
| K201745 | 2020-12-10 | JAK | Traditional | GE Medical Systems, LLC |
| K203169 | 2020-11-20 | JAK | Special | GE Healthcare Japan Corporation |
| K191777 | 2019-07-26 | JAK | Special | GE Medical Systems, LLC |
| K191699 | 2019-07-24 | KPR | Traditional | Ge Hualun Medical Systems Co., Ltd. |
| K183202 | 2019-04-12 | JAK | Traditional | GE Medical Systems, LLC |
| K182626 | 2018-11-16 | OXO | Traditional | Ge Hualun Medical Systems Co., Ltd. |
| K181403 | 2018-11-02 | OWB | Traditional | GE Healthcare GmbH |
| K173816 | 2018-04-17 | KPS | Traditional | GE Healthcare GmbH |
| K173612 | 2017-12-11 | KPR | Special | Ge Hualun Medical Systems Co., Ltd. |
| K172700 | 2017-11-09 | OWB | Traditional | Ge Hualun Medical Systems Co., Ltd. |
| K172869 | 2017-10-20 | KPR | Special | Ge Hualun Medical Systems Co., Ltd. |
| K171800 | 2017-07-12 | OXO | Special | Ge Hualun Medical Systems Co., Ltd. |
| K153355 | 2016-03-16 | LLZ | Traditional | GE Healthcare GmbH |
| K153429 | 2016-03-09 | JAK | Traditional | Ge Hangwei Medical System Co., Ltd. |
| K151372 | 2015-08-14 | JAK | Traditional | GE Medical Systems, LLC |
| K143270 | 2015-02-18 | KPR | Traditional | Ge Hualun Medical Systems Co., Ltd. |
| K132410 | 2014-01-17 | JAK | Traditional | GE Medical Systems, LLC |
| K132261 | 2013-11-18 | IZF | Traditional | GE Medical Systems, LLC |
| K131576 | 2013-08-30 | JAK | Traditional | GE Medical Systems, LLC |
| K123603 | 2013-05-17 | OXO | Traditional | Ge Healthcare Surgery GE Oec Medical Systems, Inc. |
| K130884 | 2013-04-12 | LLZ | Traditional | Ge Medical Systems F.I. Haifa |
| K122457 | 2013-01-02 | OWB | Traditional | GE Healthcare GmbH |
| K120833 | 2012-06-12 | JAK | Special | GE Medical Systems, LLC |
| K113350 | 2011-12-05 | KPS | Special | GE Healthcare GmbH |
| K103448 | 2011-08-12 | KPR | Traditional | GE Medical Systems, LLC |
| K110227 | 2011-07-20 | JAK | Special | GE Medical Systems, LLC |
| K103476 | 2011-06-16 | IZL | Traditional | GE Medical Systems, LLC |
| K111445 | 2011-06-03 | KPS | Traditional | GE Healthcare GmbH |
| K093581 | 2011-04-19 | JAK | Traditional | GE Medical Systems, LLC |
| K102615 | 2010-11-18 | MQB | Traditional | GE Medical Systems, LLC |
| K093514 | 2009-12-10 | KPS | Traditional | Ge Medical Systems F.I. Haifa |
| K082960 | 2008-10-17 | JAK | Traditional | GE Medical Systems, LLC |
| K082816 | 2008-10-08 | JAK | Traditional | GE Medical Systems, LLC |
| K051967 | 2005-08-09 | KPR | Traditional | GE Healthcare GmbH |
| K993090 | 1999-10-01 | KPR | Traditional | GE Medical Systems, LLC |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-11-07 | Class II | Process design | 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 ( | 134 units | |
| 2023-11-07 | Class II | Process design | 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 ( | 68 units | |
| 2013-09-18 | Class II | Device Design | 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. | 29 | 2014-01-27 |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.