Volcano iFR Harvest Software (Offline)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K143122 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 iFR Harvest Software (Offline) is an offline analysis tool for the vasodilator-free pressure measurement module, iFR Modality, of the Volcano s5/s5i/CORE and CORE Mobile systems. It is designed to calculate iFR values from hyperemia-free FFR pressure recordings in a laptop or desktop setting only.
This software is supplied as part of the Volcano iFR system and is intended for offline analysis. It is a Class II device cleared by the FDA with a 510(k) number K143122, received on 2014-10-31 and decided as substantially equivalent on 2015-02-20. The device is regulated under product code IYO and is reviewed by the Radiology advisory committee.
Frequently asked questions
What is the Volcano iFR Harvest Software (Offline) used for?
The Volcano iFR Harvest Software (Offline) is an offline analysis tool designed to calculate iFR values from hyperemia-free FFR pressure recordings. It works with the iFR Modality of the Volcano s5/s5i/CORE and CORE Mobile systems and operates exclusively on laptop or desktop computers.
How is the Volcano iFR Harvest Software supplied?
The software is supplied as part of the Volcano iFR system. It is intended specifically for offline analysis purposes and requires a laptop or desktop environment to function properly.
What is the regulatory status of the Volcano iFR Harvest Software?
The Volcano iFR Harvest Software (Offline) is a Class II device cleared by the FDA with a 510(k) number K143122. It was received on 2014-10-31 and decided as substantially equivalent on 2015-02-20. The device is regulated under product code IYO and reviewed by the Radiology advisory committee.
Which systems are compatible with the Volcano iFR Harvest Software?
The Volcano iFR Harvest Software (Offline) is compatible with the iFR Modality of the Volcano s5/s5i/CORE and CORE Mobile systems. It is designed to work with these specific systems for offline analysis of pressure recordings.
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 iFR Harvest Software (Offline) (K143122) - Innolitics, Volcano IFR Harvest Software (Offline) 510(k) K143122 - fda.report, Volcano iFR Harvest Software (Offline) | allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K143122 | Class II | Active |
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Manufacturer
- Manufacturer
- Volcano Corporation
Sources (1)
- FDA 510(k) K143122 24 fields · synced Sep 26, 2026