Cleared Traditional

Clarius Ultrasound Scanner

K180799 · Clarius Mobile Health Corp. · Radiology
May 2018
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K180799 is an FDA 510(k) clearance for the Clarius Ultrasound Scanner, 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 May 14, 2018, 48 days after receiving the submission on March 27, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K180799 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2018
Decision Date May 14, 2018
Days to Decision 48 days
Submission Type Traditional
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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