Interventional Angiography System
Catalogue number INFX-8000V, 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) | K081582 |
| Record published | 2016-09-01 |
| Record revised | 2026-06-10 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| INFX-8000V | 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
9 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 | 2026-08-04 | Class II | Process control | Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose. | 10 systems | |
| Canon Medical System, USA, Inc. | 510(k) number | 2022-01-31 | Class II | Software design | The fluoroscopic dose rate might exceed the conforming value during biplane fluoroscopy. | 16 systems | |
| Canon Medical System, USA, Inc. | 510(k) number | 2021-12-20 | Class II | Vendor change control | Abnormal images such as horizontal stripes may be displayed and recovery may not not be possible by restarting the system. The worst case scenario is an operator who is working without a workable image may remove a catheter from the patient | 8 | |
| Canon Medical System, USA, Inc. | 510(k) number | 2021-02-05 | Class II | Software design | The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles. | 272 in total | |
| Canon Medical System, USA, Inc. | 510(k) number | 2020-12-08 | Class II | Component design/selection | System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose. | Total of all Systems = 145 systems (U.S.) | |
| Canon Medical System, USA, Inc. | 510(k) number | 2020-03-03 | Class II | Process control | Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting. | 46 | |
| Toshiba American Medical Systems Inc | 510(k) number | 2017-12-29 | Class II | Process control | During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error. | 29 units | 2023-11-29 |
| Toshiba American Medical Systems Inc | 510(k) number | 2015-08-14 | Class II | Radiation Control for Health and Safety Act | When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an “ab | 4 | 2016-05-18 |
| Toshiba American Medical Systems Inc | 510(k) number | 2015-03-11 | Class II | Device Design | The table base rotational brake that holds the table top may not always be engaged when any force or side impact is applied to the table top. | 28 units | 2015-09-18 |
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.