Cleared Traditional

Clarius OB AI

K233955 · Clarius Mobile Health Corp. · Radiology
Jun 2024
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K233955 is an FDA 510(k) clearance for the Clarius OB AI, 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 June 14, 2024, 182 days after receiving the submission on December 15, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K233955 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2023
Decision Date June 14, 2024
Days to Decision 182 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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