Cleared Traditional

VOLCANO IFR MODALITY

K133323 · Volcano Corporation · Radiology
Mar 2014
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K133323 is an FDA 510(k) clearance for the VOLCANO IFR MODALITY, 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 14, 2014, 136 days after receiving the submission on October 29, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K133323 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 2013
Decision Date March 14, 2014
Days to Decision 136 days
Submission Type Traditional
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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