VS3 Stereoscopic High Definition Vision System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K141002 FDA 510(k)
- FDA Product Code
- HRX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.1100 FDA 510(k)
- Regulation Number
- 888.1100 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The VS3 Stereoscopic High Definition Vision System is a stereoscopic high-definition vision system for surgical visualization. It provides stereoscopic 3-dimensional (3D) viewing using a proximal HD camera concept with a stereoscopic camera block at the endoscope handle to capture 3D video.
System components include a rigid stainless steel endoscope, light source, camera control unit (CCU), camera, and display monitors. The device is authorized under FDA 510(k) clearance K141002 and is substantially equivalent to the Visionsense VSu Stereoscopic Vision System (K073279).
Frequently asked questions
What is the VS3 Stereoscopic High Definition Vision System used for?
The VS3 Stereoscopic High Definition Vision System is used for surgical visualization, providing stereoscopic 3-dimensional (3D) viewing to enhance depth perception during procedures by capturing 3D video through a stereoscopic camera block at the endoscope handle.
What components are included in the VS3 Stereoscopic High Definition Vision System?
The system includes a rigid stainless steel endoscope, light source, camera control unit (CCU), camera, and display monitors, which work together to deliver stereoscopic high-definition 3D video for surgical visualization.
How is the VS3 Stereoscopic High Definition Vision System authorized for use?
The VS3 Stereoscopic High Definition Vision System is authorized under FDA 510(k) clearance K141002 and is substantially equivalent to the Visionsense VSu Stereoscopic Vision System (K073279), meaning it has been reviewed and cleared for marketing based on its similarity to a legally marketed device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Vs3 Stereoscopic High Definition Vision System, Vs3 Stereoscopic High Definition Vision System, VS3 by VISIONSENSE, LTD. | FDA 510 (k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141002 | Class II | Active |
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Manufacturer
- Manufacturer
- Visionsense Ltd.
- FDA Applicant
- Visionsense, Ltd.
Sources (1)
- FDA 510(k) K141002 24 fields · synced Sep 23, 2026