Cleared Abbreviated

Clarius Ultrasound System

K172385 · Clarius Mobile Health Corp. · Radiology
Sep 2017
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K172385 is an FDA 510(k) clearance for the Clarius Ultrasound System, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Clarius Mobile Health Corp. (Burnaby, CA). The FDA issued a Cleared decision on September 14, 2017, 37 days after receiving the submission on August 8, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K172385 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2017
Decision Date September 14, 2017
Days to Decision 37 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1550

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