Genoray
10 catalogue numbers from VETERA TURBO, listed by Genoray Co., Ltd., South Korea, under Interventional Fluoroscopic X-Ray System. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
10catalogue numbers in this listing
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Guangdong (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 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Genoray Co., Ltd., South Korea |
|---|---|
| FDA product code | OWB |
| Device type | Interventional Fluoroscopic X-Ray System |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Manufacturer |
| 510(k) | K211780 |
| Record published | 2025-12-01 |
| Record revised | 2023-12-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VETERA TURBO | In distribution | |
| OSCAR Classic | In distribution | |
| BELLIGER ACE | In distribution | |
| AREX | In distribution | |
| ZEN-2090 Turbo | In distribution | |
| VETERA ACE | In distribution | |
| ZEN-2090 Turbo | In distribution | |
| VETERA PRIME | In distribution | |
| VETERA CLASSIC | In distribution | |
| OSCAR Prime | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TrackX | Trackx Technology Inc. | 86 |
| Trinias | Shimadzu Corp. | 54 |
| Allura Xper FD | Philips Medical Systems Nederland B.V. | 21 |
| Azurion | Philips Medical Systems Nederland B.V. | 19 |
| LessRay | Nuvasive, Inc. | 16 |
| Intelli-C Accessory | Nrt – Nordisk Røntgen Teknik A/S | 13 |
| Pulse | Nuvasive, Inc. | 12 |
| O-ARM® | Medtronic Navigation, Inc. | 11 |
| Fujifilm Healthcare Americas Corporation | A.T.S. Applicazione Tecnologie Speciali SRL | 7 |
| Fujifilm Medical Systems U.S.A. Inc. | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
| Stephanix | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
| Amrad Medical | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
Showing 12 of 122. All products under Interventional Fluoroscopic X-Ray System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252229 | 2026-04-02 |
| K230787 | 2023-07-20 |
| K211780 | 2022-03-09 |
| K181943 | 2018-08-17 |
| K172180 | 2018-02-09 |
| K140041 | 2014-11-28 |
| K091918 | 2009-10-07 |
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.