Volcano S5iintravascular Imaging And Pressure System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K111706 FDA 510(k)
- FDA Product Code
- IYO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Volcano S5i Intravascular Imaging And Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It provides an image of vessel lumen and wall as an adjunct to conventional angiographic procedures.
The system is supplied by Volcano Corporation and has received FDA 510K authorization. It is intended for use in radiology applications, with the product code IYO, and has been assigned the k number K111706.
Frequently asked questions
What is the Volcano S5i system used for?
The Volcano S5i system is used for the qualitative and quantitative evaluation of vascular morphology in coronary arteries and peripheral vasculature, as an adjunct to conventional angiographic procedures.
Is the Volcano S5i system supplied sterile?
The description does not specify if the system is supplied sterile, but it is intended for use in radiology applications.
What is the regulatory status of the Volcano S5i system?
The Volcano S5i system has received FDA 510K authorization, indicating it is substantially equivalent to a predicate 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: Volcano S5iintravascular Imaging and Pressure System, Volcano S5iintravascular Imaging and Pressure System, Volcano S5/S5i Intravascular Ultrasound Imaging and Pressure System ..., s5 Intravascular Ultrasound Imaging and Pressure Systems s5i ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111706 | Class II | Active |
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Manufacturer
- Manufacturer
- Volcano Corporation
Sources (1)
- FDA 510(k) K111706 24 fields · synced Sep 26, 2026