Cleared Abbreviated

Clarius Ultrasound Scanner

K192107 · Clarius Mobile Health Corp. · Radiology
Aug 2019
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K192107 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 August 29, 2019, 24 days after receiving the submission on August 5, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K192107 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2019
Decision Date August 29, 2019
Days to Decision 24 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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