UR-X
2 catalogue numbers from 1921067050, listed by Teac Manufacturing Solutions Corporation, Japan, under Device, Digital Image Storage, Radiological. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Hebei (1), Guangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Bgss Company Asia Limited | Zhabei | Shanghai | Contract manufacturer | 25 |
| Dongguan Teac Electronics Co., Ltd. | Dong Guan | Guangdong | Manufacturer | 1 |
Record
| Listed by | Teac Manufacturing Solutions Corporation, Japan |
|---|---|
| FDA product code | LMB |
| Device type | Device, Digital Image Storage, Radiological |
| Device class | Class 1 |
| Regulation | 21 CFR 892.2010 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-02 |
| Record revised | 2023-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1921067050 | In distribution | |
| 1921067051 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Roentgen Works | Brit Systems | 71 |
| Evolution4K | NDS Surgical Imaging, LLC. | 40 |
| UR-4MD | Dongguan Teac Electronics Co., Ltd. | 19 |
| Vitegra® | Joimax Gmbh | 16 |
| DMC-EZ | Storage Solutions Technology Group Inc. | 13 |
| 660HD-E Image Management System | Smith & Nephew, Inc. | 13 |
| 4Klearity | NDS Surgical Imaging, LLC. | 11 |
| Hdmd PRO | NDS Surgical Imaging, LLC. | 8 |
| UniRay | Uniray Medical LLP | 8 |
| nCare | Gyrus Acmi, Inc. | 7 |
| EvolutionHD | NDS Surgical Imaging, LLC. | 7 |
| UR-NEXT4KH | Teac Manufacturing Solutions Corporation | 7 |
Showing 12 of 44. All products under Device, Digital Image Storage, Radiological
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.