Multipurpose Remote Control R/F System
Catalogue number DREX-UI80, listed by Canon Inc., Japan, under Interventional Fluoroscopic X-Ray System. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
4510(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 | Canon Inc., Japan |
|---|---|
| FDA product code | OWB |
| Device type | Interventional Fluoroscopic X-Ray System |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K143281 |
| Record published | 2016-09-01 |
| Record revised | 2026-03-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DREX-UI80 | 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 |
| Genoray | Genoray Co., Ltd. | 10 |
| 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 |
Showing 12 of 122. All products under Interventional Fluoroscopic X-Ray System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252503 | 2026-04-30 |
| K232298 | 2024-04-26 |
| K200887 | 2020-04-15 |
| K171194 | 2017-05-24 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Canon Medical System, USA, Inc. | 510(k) number | 2020-07-08 | Class II | Software design | During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the same as originally acquired. | 11 units | |
| Toshiba American Medical Systems Inc | 510(k) number | 2017-03-15 | Class II | Software design | The issue was identified as a firmware problem with the generator. | 18 | 2020-09-25 |
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.