SkyVision
SkyVision LINX 300 Digital Integration system includes: Medical Grade Touch Panel, Optical Router, IP addressable Control Switch and On-Board Uninterruptable Power Supply.
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 | Skytron, LLC, 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -4 to 140 °F |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SDS | In distribution | |
| LINX 300 | In distribution | |
| Ascend Eco | 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
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-09-11 | Class II | Software design | VGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a secondary display. Video would continue on the primary source device display | 11 units | 2024-09-24 |
| 2020-03-10 | Class II | Software Manufacturing/Software Deployment | Intermittent failure of a signal being sent to a monitor from the touch panel display causing the displaying monitor to go Blank and the touch panel to display a Blank image when reviewing the target display. If this issue were to happe | 36 units | 2021-06-01 |
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.