Canon Inc.
20 catalogue numbers from CXDI-501G, 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
20catalogue 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) | K111682 |
| Record published | 2016-09-24 |
| Record revised | 2026-03-20 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CXDI-501G | In distribution | |
| CXDI-55G | In distribution | |
| CXDI-801C Wireless | In distribution | |
| D1 | In distribution | |
| CXDI-810C Wireless | In distribution | |
| CXDI-701C Wireless | In distribution | |
| CXDI-401G COMPACT | In distribution | |
| CXDI-70C Wireless | In distribution | |
| CXDI-501C | In distribution | |
| CXDI-710C Wireless | In distribution | |
| CXDI-701G Wireless | In distribution | |
| CXDI-702C Wireless | In distribution | |
| CXDI-402C Wireless | In distribution | |
| CXDI-401C COMPACT | In distribution | |
| CXDI-Pro | In distribution | |
| CXDI-55C | In distribution | |
| CXDI-401C Wireless | In distribution | |
| CXDI-801G Wireless | In distribution | |
| CXDI-410C Wireless | In distribution | |
| CXDI-Elite | 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 |
| 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 |
| Aadco | Aadco Medical, Inc. | 15 |
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
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Canon Inc. | 510(k) number | 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.