Cleared Special

CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit

K172455 · Volcano Corporation · Radiology
Oct 2017
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K172455 is an FDA 510(k) clearance for the CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit, 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 October 25, 2017, 72 days after receiving the submission on August 14, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K172455 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2017
Decision Date October 25, 2017
Days to Decision 72 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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