Vitegra®
Footswitch for Vitegra®3 for Video/Image capture
6manufacturers in China registered for this device type
16catalogue 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 | Joimax Gmbh, Germany |
|---|---|
| FDA product code | LMB |
| Device type | Device, Digital Image Storage, Radiological |
| Device class | Class 1 |
| Regulation | 21 CFR 892.2010 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 70 °C; Storage environment humidity 10 to 100 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ICS1710.100 | In distribution | |
| ICS0401S | Fully integrated Full HD documentation system | In distribution |
| ICFSHD001 | In distribution | |
| ICS1900 | In distribution | |
| ICS1900IO | In distribution | |
| JESTTHS | VESA 75/100, charging station | In distribution |
| ICS1710 | visual integration image capture system | In distribution |
| ICWSR400S | In distribution | |
| ICS0401 | In distribution | |
| ICRA410G | In distribution | |
| ICS0401D | License key for enabling the DICOM functionality | In distribution |
| ICS1710FS | visual integration image capture system | In distribution |
| ICS0401T | In distribution | |
| ICWSR400 | In distribution | |
| JESTTH | In distribution | |
| ICFSV002 | 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 |
| 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 |
| Viron R4K | NDS Surgical Imaging, LLC. | 5 |
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.