Cleared Special

Clarius Ultrasound Scanner

K213436 · Clarius Mobile Health Corp. · Radiology
Nov 2021
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K213436 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. (Vancouver, CA). The FDA issued a Cleared decision on November 15, 2021, 24 days after receiving the submission on October 22, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K213436 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 2021
Decision Date November 15, 2021
Days to Decision 24 days
Submission Type Special
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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