Cleared Special

Volcano iFR Modality, iFR Scout feature

K150441 · Volcano Corporation · Radiology
Mar 2015
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K150441 is an FDA 510(k) clearance for the Volcano iFR Modality, iFR Scout feature, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on March 20, 2015, 28 days after receiving the submission on February 20, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K150441 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2015
Decision Date March 20, 2015
Days to Decision 28 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1560

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