SonoScape
HD-500Plus Image Processor
3manufacturers in China registered for this device type
10catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Sonoscape Medical Corp. | Shenzhen | Guangdong | Manufacturer | 7 |
Record
| Listed by | Sonoscape Medical Corp., China |
|---|---|
| FDA product code | NWB |
| Device type | Endoscope, Accessories, Narrow Band Spectrum |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer |
| Record published | 2022-04-07 |
| Record revised | 2026-04-08 (version 2) |
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 |
|---|---|---|
| VLS-55T | In distribution | |
| VLS-51T | In distribution | |
| VLS-51D | In distribution | |
| HD-550Exp | In distribution | |
| HD-550 | In distribution | |
| HD-510 | In distribution | |
| HD-550S | In distribution | |
| HD-500Plus | In distribution | |
| VLS-55Q | In distribution | |
| HD-550Pro | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medisono | Medisono, LLC | 10 |
| Evis Exera II Colonovideoscope | Olympus Medical Systems Corp. | 8 |
| Rhino-Laryngo Videoscope | Olympus Medical Systems Corp. | 7 |
| Evis Exera II Gastrointestinal Videoscope | Olympus Medical Systems Corp. | 7 |
| Visera Cysto-Nephro Videoscope | Olympus Medical Systems Corp. | 6 |
| Uretero-Reno Videoscope | Olympus Medical Systems Corp. | 4 |
| Cysto-Nephro Videoscope | Olympus Medical Systems Corp. | 4 |
| Olympus | Olympus Winter & IBE Gmbh | 4 |
| Foot Holder | Olympus Medical Systems Corp. | 3 |
| Light source cable | Olympus Medical Systems Corp. | 3 |
| Foot Switch | Olympus Medical Systems Corp. | 3 |
| Evis Exera II Duodenovideoscope | Olympus Medical Systems Corp. | 3 |
Showing 12 of 66. All products under Endoscope, Accessories, Narrow Band Spectrum
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222020 | 2022-09-08 |
| K211882 | 2022-04-01 |
| K173921 | 2018-09-05 |
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.