Volcano iFR Modality, iFR Scout feature
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150441 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 Modality with iFR Scout Feature is a Class II ultrasound system designed for physiological assessment of coronary and peripheral artery lesions. It employs fractional flow reserve (iFR) technology to evaluate vessel function without the need for hyperemic agents, enabling resting-state measurements. This modality supports diagnostic imaging in radiology settings, providing quantitative data to guide interventional decisions. The iFR Scout feature enhances its capability by facilitating pullback measurements for serial lesion analysis.
This device is supplied as a software feature integrated into the Volcano iFR Modality system, requiring compatibility with existing hardware. It is intended for single-use applications in controlled clinical environments, though sterility and reuse specifications are not explicitly detailed. The system carries FDA 510(k) clearance (K150441) under the Special Review Advisory Committee (RA) for Radiology, granted in March 2015. No additional regulatory markings or MRI safety classifications are provided in the available data.
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 Modality, iFR Scout feature (K150441) — FDA 510 (k ..., Volcano iFR Modality, iFR Scout Feature - allmed.wiki, Volcano iFR Modality, iFR Scout Feature - allmed.wiki, PDF An Introduction to iFR ScoutTM Pullback Measurements
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150441 | Class II | Active |
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Manufacturer
- Manufacturer
- Volcano Corporation
Sources (1)
- FDA 510(k) K150441 24 fields · synced Sep 20, 2026