Cleared Abbreviated

Clarius Ultrasound System

K163138 · Clarius Mobile Health Corp. · Radiology
Nov 2016
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K163138 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 November 30, 2016, 21 days after receiving the submission on November 9, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K163138 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2016
Decision Date November 30, 2016
Days to Decision 21 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

Similar Devices — IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 1150
Sonosite iLOOK Ultrasound System
K260595 · FUJIFILM Sonosite, Inc. · Mar 2026
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System
K253049 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Feb 2026
Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
K253597 · Canon Medical Systems Corporation · Jan 2026
LOGIQ Totus
K253370 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jan 2026
LOGIQ Fortis
K253366 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jan 2026
HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System
K252018 · Samsung Medison Co., Ltd. · Jan 2026