Identifiers
- 510(k) Number
- K223020 FDA 510(k)
- FDA Product Code
- OWN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The VS3-Iridium System (VS3-IR) is a confocal optical imaging device designed for fluorescence imaging. It visualizes vessels, blood flow, and tissue perfusion using indocyanine green (ICG) during minimally invasive and reconstructive surgical procedures, providing real-time assessment of vascular integrity and perfusion dynamics.
The system is supplied as a reusable medical device and is intended for use in clinical settings such as operating rooms. It operates under sterile conditions when used with single-use ICG, adhering to Class II regulatory standards. The VS3-IR includes multiple imaging modules and is authorized for use in gastroenterology and urology procedures, with FDA 510(k) clearance (K223020) and regulatory classification under 876.1500. Storage and handling follow standard medical device protocols to ensure functionality and sterility.
Frequently asked questions
What is the VS3-Iridium System (VS3-IR) used for in surgical procedures?
The VS3-Iridium System (VS3-IR) is a confocal optical imaging device designed for fluorescence imaging. It visualizes blood vessels, blood flow, and tissue perfusion using indocyanine green (ICG) during minimally invasive and reconstructive surgeries. This real-time assessment helps clinicians evaluate vascular integrity and perfusion dynamics, ensuring safer surgical outcomes in procedures like those in gastroenterology and urology.
How is the VS3-Iridium System (VS3-IR) supplied and what are its sterility requirements?
The VS3-Iridium System (VS3-IR) is supplied as a reusable medical device. When used clinically, it operates under sterile conditions, particularly when combined with single-use indocyanine green (ICG). This ensures that the imaging system itself remains functional and adheres to standard medical device sterility protocols for safe use in operating rooms.
Is the VS3-Iridium System (VS3-IR) approved for specific medical specialties?
Yes, the VS3-Iridium System (VS3-IR) is authorized for use in gastroenterology and urology procedures. Its FDA 510(k) clearance (K223020) and regulatory classification under 876.1500 confirm its suitability for these specialized fields, where assessing vascular integrity and perfusion is critical.
What storage and handling protocols should be followed for the VS3-Iridium System (VS3-IR)?
The VS3-Iridium System (VS3-IR) must be stored and handled according to standard medical device protocols to maintain its functionality and sterility. This includes proper cleaning, maintenance, and storage conditions to ensure the device remains operational and safe for use in clinical settings, particularly in operating rooms where sterility is paramount.
Does the VS3-Iridium System (VS3-IR) include multiple imaging modules?
Yes, the VS3-Iridium System (VS3-IR) includes multiple imaging modules as part of its design. These modules enable versatile fluorescence imaging capabilities, allowing clinicians to assess vascular structures and perfusion dynamics effectively during surgical procedures.
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: PDF Visionsense Ltd. Guy Wroclawski Senior Regulatory Affairs Specialist, VS3-Iridium System (VS3-IR) (K223020) - FDA 510 (k), PDF Visionsense Ltd., VS3-Iridium System (VS3-IR) (K223020) - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223020 | Class II | Active |
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Manufacturer
- Manufacturer
- Visionsense Ltd.
- FDA Applicant
- Visionsense, Ltd.
Sources (1)
- FDA 510(k) K223020 24 fields · synced Oct 1, 2026