OEC
ASM, OEC Brivo Essential US UDI configuration
3manufacturers in China registered for this device type
2catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Beijing (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
Record
| Listed by | Ge Hualun Medical Systems Co., Ltd., China |
|---|---|
| FDA product code | OXO |
| Device type | Image-Intensified Fluoroscopic X-Ray System, Mobile |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| 510(k) | K160131 |
| Record published | 2016-08-26 |
| Record revised | 2025-04-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Elite MiniView | In distribution | |
| Brivo Essential | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| O-ARM® | Medtronic Navigation, Inc. | 16 |
| Cios Select | Siemens Shanghai, Medical Equipment Ltd. | 3 |
| Smart-C | Turner Imaging Systems, Inc. | 3 |
| Zenition | Philips Medical Systems Nederland B.V. | 2 |
| Broach Set SPX1 | Ecential Robotics | 2 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | Ecotron Co., Ltd. | 2 |
| Flourocsan InSight | Hologic, Inc. | 2 |
| Genoray | Genoray Co., Ltd. | 2 |
| 3D Imaging Set SPX1 | Ecential Robotics | 2 |
| Discovery | GE Medical Systems, LLC | 2 |
| Cios Alpha | Siemens Healthcare Limited | 1 |
| System, X-RAY, Fluoroscopic, Image-Intensified | Gemss Medical Systems Co., Ltd. | 1 |
Showing 12 of 40. All products under Image-Intensified Fluoroscopic X-Ray System, Mobile
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253269 | 2025-11-26 |
| K240828 | 2024-12-27 |
| K182626 | 2018-11-16 |
| K171800 | 2017-07-12 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE OEC Medical Systems, Inc | 510(k) number | 2016-09-23 | Class II | Nonconforming Material/Component | GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls vertical motion of the C-arm may fail, resulting in the C-Arm m | 148 total | 2017-04-24 |
| GE OEC Medical Systems, Inc | 510(k) number | 2014-09-15 | Class II | Radiation Control for Health and Safety Act | mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance | 61 units installed in US | 2015-05-20 |
| GE OEC Medical Systems, Inc | 510(k) number | 2014-09-15 | Class II | Radiation Control for Health and Safety Act | mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance | 61 units installed in US | 2015-05-20 |
| GE OEC Medical Systems, Inc | 510(k) number | 2014-05-22 | Class II | Radiation Control for Health and Safety Act | Laser aimer assemblies were shipped without certification of the overall assembly or submitting a laser product report and therefore do not comply with the US regulations for laser products. | 9 | 2015-06-24 |
| GE Hangwei Medical Systems Co., Ltd. | 510(k) number | 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 |
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.