Depuy Synthes
Evolution4K Recording System - Quad SDI Version, Branded for Depuy Synthes
6manufacturers in China registered for this device type
3catalogue 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 | NDS Surgical Imaging, LLC., United States |
|---|---|
| FDA product code | LMB |
| Device type | Device, Digital Image Storage, Radiological |
| Device class | Class 1 |
| Regulation | 21 CFR 892.2010 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-09-23 |
| Record revised | 2024-11-26 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 70 °C; Storage environment humidity from 94 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment atmospheric pressure 70 to 105 KiloPascal; Handling environment humidity from 85 % RH; Handling environment temperature 16 to 26 °C |
| Distribution end date | 2023-06-27 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Evo4K220 | Withdrawn | |
| Evo4K220 | Withdrawn | |
| Evo4K220 | Withdrawn |
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.