IMRISmatrix 5.0
Applications Platform 5.0 3 Room, North America, Japan
6manufacturers in China registered for this device type
1catalogue number
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 | Imris Imaging, Inc., United States |
|---|---|
| FDA product code | LMB |
| Device type | Device, Digital Image Storage, Radiological |
| Device class | Class 1 |
| Regulation | 21 CFR 892.2010 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-09-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P122309 | 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.