GE Hangwei Medical Systems, Co. Ltd
Beijing, CN
GE HANGWEI MEDICAL SYSTEMS CO., LTD. appears in FDA device records in Beijing, CN. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to GE Hangwei Medical Systems, Co. Ltd carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- GE Healthcare Beijing , Hangwei Medical Systems, Co. LTDenforcement report, recall
510(k) clearance history
FDA records hold 10 510(k) clearances for GE Hangwei Medical Systems, Co. Ltd between 2011 and 2024. The busiest year on record is 2012, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233749 | Revolution Ascend Sliding | JAK | Substantially Equivalent | |
| K192956 | Auto Positioning | JAK | Substantially Equivalent | |
| K192686 | Revolution Maxima, Revolution Ace | JAK | Substantially Equivalent | |
| K171013 | Revolution ACT | JAK | Substantially Equivalent | |
| K160131 | OEC Elite MiniView | OXO | Substantially Equivalent | |
| K123596 | OPTIMA CT520 | JAK | Substantially Equivalent | |
| K123417 | BRIVO MR355, OPTIMA MR360 | LNH | Substantially Equivalent | |
| K122694 | GE 8CH FOOT ANKLE COIL | MOS | Substantially Equivalent | |
| K120778 | BRIVO MR355 | LNH | Substantially Equivalent | |
| K103330 | BRIVO MR355, OPTIMA MR360 | LNH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9613445 | 3002175190 | GE HANGWEI MEDICAL SYSTEMS CO., LTD. | West Area of Building No.3, No.1 Yongchang North Road, Beijing 100176 CN | 2026 | and 12 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ITYAssembly, Tube Housing, X-Ray, Diagnostic
- QIHAutomated Radiological Image Processing Software
- IYZBed, Scanning, Nuclear
- MOSCoil, Magnetic Resonance, Specialty
- IZWCollimator, Automatic, Radiographic
- KGIDensitometer, Bone
- IXYHolder, Radiographic Cassette, Wall-Mounted
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile
- LHOInstrument, Quality-Assurance, Radiologic
- OWBInterventional Fluoroscopic X-Ray System
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
- CCXSupport, Patient Position
- LLZSystem, Image Processing, Radiological
- LNHSystem, Nuclear Magnetic Resonance Imaging
- KPSSystem, Tomography, Computed, Emission
- IZISystem, X-Ray, Angiographic
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- IZLSystem, X-Ray, Mobile
- KPRSystem, X-Ray, Stationary
- IZFSystem, X-Ray, Tomographic
- JAKSystem, X-Ray, Tomography, Computed
- IZZTable, Radiographic, Non-Tilting, Powered
- IXRTable, Radiographic, Tilting
- IYBTube Mount, X-Ray, Diagnostic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0553-2024 | 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 verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on. | 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. | Class II | Open, Classified | |
| Z-0552-2024 | 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 verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on. | 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. | Class II | Open, Classified | |
| Z-0066-2014 | 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 pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy. | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain