X-Ray App
Catalogue number 12-00001, listed by Treace Medical Concepts, Inc., United States, under System, Digital Image Communications, Radiological. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (4), Tianjin (1), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Coretronic Projection (Kunshan) Corporation | Kunshan | Jiangsu | Contract manufacturer | 3 |
| AUO (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| Nanjing Jusha Display Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 7 |
| Barco (Suzhou) Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Beijing Visual Perception Intelligence Technology Co., Ltd. | Tianjin | Tianjin | Manufacturer | 1 |
| E-COM Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
Record
| Listed by | Treace Medical Concepts, Inc., United States |
|---|---|
| FDA product code | LMD |
| Device type | System, Digital Image Communications, Radiological |
| Device class | Class 1 |
| Regulation | 21 CFR 892.2020 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-05-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12-00001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitrea Advanced Visualization | Canon Medical Informatics, Inc. | 34 |
| Barco | Barco, Inc | 27 |
| RadiForce® | Eizo Corporation | 23 |
| Vitrea Read | Canon Medical Informatics A/S | 19 |
| Image Diagnostics, Inc | Image Diagnostics, Inc. | 19 |
| ScaleOR | NDS Surgical Imaging, LLC. | 17 |
| interWORKS | Avreo, Inc. | 16 |
| Vitrea View | Canon Medical Informatics, Inc. | 14 |
| Clinical review 2MP | Barco, Inc | 11 |
| Barco | Fimi SRL | 10 |
| Super Ulstar | Durico C&T, Inc. | 9 |
| VISIUSmatrix | Imris Imaging, Inc. | 9 |
Showing 12 of 193. All products under System, Digital Image Communications, 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.