Interventional Angiography System
Catalogue number INFX-8000C, listed by Canon Inc., Japan, under System, X-Ray, Fluoroscopic, Image-Intensified. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Beijing (2), Guangdong (2), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Ming FAI Enterprise International Co., Ltd. | Kowloon | Hong Kong | Exporter | 18 |
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| 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 |
| Careray Digital Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Canon Inc., Japan |
|---|---|
| FDA product code | JAA |
| Device type | System, X-Ray, Fluoroscopic, Image-Intensified |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K113052 |
| 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 |
|---|---|---|
| INFX-8000C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Preferred Medical Products, LLC | Preferred Medical Products, LLC | 324 |
| Unbranded | Advance Medical Designs, Inc. | 301 |
| N23 CCD System | Nical SPA | 57 |
| N33 CCD System | Nical SPA | 36 |
| Trinias | Shimadzu Corp. | 31 |
| Custom Cover | Advance Medical Designs, Inc. | 15 |
| Pulse | Nuvasive, Inc. | 15 |
| Sonialvision G4 | Shimadzu Corp. | 13 |
| LessRay | Nuvasive, Inc. | 13 |
| Micro Kover | Advance Medical Designs, Inc. | 11 |
| Stephanix | Stephanix | 10 |
| Snap Kover | Advance Medical Designs, Inc. | 9 |
Showing 12 of 169. All products under System, X-Ray, Fluoroscopic, Image-Intensified
Recalls Naming This Product
9 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Canon Medical System, USA, Inc. | UDI-DI | 2023-11-15 | Class II | Component change control | VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may lead to the inability to | 1 | |
| Canon Medical System, USA, Inc. | UDI-DI | 2023-06-22 | Class II | Nonconforming Material/Component | The C-arm, used to set the position and angle of the x-ray exposure field, may not function due to the tableside console PWB, which needs replacement. There may be a delay in the procedure, but procedures can continue using the operators co | 12 | |
| Canon Medical System, USA, Inc. | 510(k) number | 2022-05-03 | Class II | Software design | CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated. | 6 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 | 2020-10-08 | Class II | Component design/selection | There is a potential that the cable of the Flat panel detector may break during a procedure which may cause the x-ray device to stop before the examination is completed. This could result in a delay with procedure and/or potential damage | 14 units | 2022-12-06 |
| 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. | 24 | |
| 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. | 19 units | 2023-11-29 |
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.