Diagnostic X-RAY System Kalare
Catalogue number DREX-KL80, 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) | K110785 |
| 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-KL80 | 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
4 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 |
|---|---|---|---|---|---|---|---|
| GE Medical Systems, LLC | 510(k) number | 2020-12-10 | Class II | Other | GE Healthcare has become aware of a potential safety issue associated with the improper installation of the Precision 600FP monitor suspension. A partial detachment of the monitor suspension could result in potential injury to a patient or | 113 units | 2022-11-18 |
| Toshiba American Medical Systems Inc | 510(k) number | 2017-09-12 | Class II | Software design | During an examination images were displayed on the live monitor,but the images were not displayed on the system monitor nor were they saved to the hard disk. | US – 96 | 2020-11-18 |
| Toshiba American Medical Systems Inc | 510(k) number | 2016-01-14 | Class II | Radiation Control for Health and Safety Act | When a user performed radiography using the wireless FPD, a message window appeared on the monitor stating that imaging transmission was not completed with no radiographic image. It also indicated to select the “OK” button to re-acquire the | 28 | 2017-02-24 |
| Toshiba American Medical Systems Inc | 510(k) number | 2013-04-03 | Class II | Component design/selection | Firm initiated recall because when radiographic conditions with the small focus are set and the radiography ready switch is held down, the large focus is also heated after a few seconds or more. This occurs when the Automatic Exposure Funct | 153 units | 2016-02-05 |
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.