Interventional Angiography System
2 catalogue numbers from INFX-8000F, listed by Canon Inc., Japan, under Solid State X-Ray Imager (Flat Panel/Digital Imager). 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
2catalogue numbers in this listing
27510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (4), Beijing (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| iRay Imaging Technology Taicang Limited | Taicang | Jiangsu | Contract manufacturer | 3 |
| 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 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| iRay Group | Shanghai | Shanghai | Specification developer | 4 |
| Fujifilm Imaging System (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Careray Digital Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
Showing 12 of 13. All 13 manufacturers in China registered for Solid State X-Ray Imager (Flat Panel/Digital Imager)
Record
| Listed by | Canon Inc., Japan |
|---|---|
| FDA product code | MQB |
| Device type | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K081624 |
| 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-8000F | In distribution | |
| INFX-8000H | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sedecal | Sedecal., Sa. | 70 |
| Schick33 | Sirona Dental, Inc. | 44 |
| Drgem | Drgem Corporation | 41 |
| Schick | Dentsply LLC | 35 |
| Wireless Digital Flat Panel Detector | iRay Group | 27 |
| Fuji IP Cassette CC | Fujifilm Corporation | 20 |
| Canon Inc. | Canon Inc. | 20 |
| Fona Stellaris | Sirona Dental, Inc. | 20 |
| Exprimer | Drtech Corporation | 18 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | Samsung Electronics Co., Ltd. | 17 |
| X-ray Flat Panel Detector | Careray Digital Medical Technology Co., Ltd. | 16 |
| Regius Cassette | Konica Minolta, Inc. | 16 |
Showing 12 of 509. All products under Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230175 | 2023-02-15 |
| K222855 | 2022-10-17 |
| K222687 | 2022-09-29 |
| K222661 | 2022-09-27 |
| K221876 | 2022-07-15 |
| K221620 | 2022-06-14 |
| K220098 | 2022-02-04 |
| K213780 | 2022-01-24 |
| K212269 | 2021-09-17 |
| K212553 | 2021-09-09 |
| K203849 | 2021-01-26 |
| K192632 | 2019-11-07 |
| K190368 | 2019-03-13 |
| K171270 | 2017-11-17 |
| K170332 | 2017-03-01 |
| K153312 | 2016-06-28 |
| K133693 | 2014-07-01 |
| K131106 | 2013-07-03 |
| K091545 | 2009-06-15 |
| K091435 | 2009-05-29 |
| K091436 | 2009-05-29 |
| K081648 | 2008-06-24 |
| K062221 | 2006-08-17 |
| K060433 | 2006-03-10 |
| K050987 | 2005-04-27 |
| K031447 | 2003-05-21 |
| K023124 | 2002-10-04 |
Recalls Naming This Product
8 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 | 2 | |
| 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. | 15 | |
| Canon Medical System, USA, Inc. | 510(k) number | 2019-02-08 | Class II | Error in labeling | Table tilts without operator involvement as a result of liquid spilling into tilt console triggering a short circuit. | 9 systems | 2022-06-07 |
| Toshiba American Medical Systems Inc | 510(k) number | 2012-11-08 | Class II | Software design | Lost and incorrect images. When using the “F-Rec” fluoroscopy image acquisition recording option in the “manual mode” an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may b | 95 units | 2013-03-26 |
| Toshiba American Medical Systems Inc | 510(k) number | 2011-10-03 | Not classified | Device Design | The recall was initiated because Toshiba has confirmed that during patient transfer from a gurney to the catherization table, the tabletop may rotate unexpectedly when sufficient force is applied to the tabletop. The result of the tabletop | 300 units | 2013-03-18 |
| Toshiba American Medical Systems Inc | 510(k) number | 2008-09-29 | Not classified | Software design | Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in for selection of High Level Controls, as required by regulation. | 129 | 2012-10-04 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-11-01 | Class II | Nonconforming Material/Component | Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor. | 468 units | 2014-01-07 |
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.