Cleared Special

IntraSight Mobile

K203719 · Volcano Corporation · Cardiovascular
Jan 2021
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K203719 is an FDA 510(k) clearance for the IntraSight Mobile, 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 January 19, 2021, 29 days after receiving the submission on December 21, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K203719 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2020
Decision Date January 19, 2021
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
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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