Volcano iFR Modality, iFR Scout feature

Volcano iFR Modality, iFR Scout feature is an FDA 510(k)-cleared medical device (K150441) manufactured by Volcano Corporation. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 19, 2015. Regulation: 8.