Cleared Special

K213436 - Clarius Ultrasound Scanner

K213436 is the FDA 510(k) clearance for Clarius Ultrasound Scanner by Clarius Mobile Health Corp.. It is a Class 2 Radiology device (product code IYN) cleared through the Special 510(k) pathway after a 24-day FDA review.

K213436 · Clarius Mobile Health Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2021
Decision
24d
Days
Class 2
Risk

K213436 is an FDA 510(k) clearance for the Clarius Ultrasound Scanner. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Clarius Mobile Health Corp. (Vancouver, CA). The FDA issued a Cleared decision on November 15, 2021 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Clarius Mobile Health Corp. devices

Submission Details

510(k) Number K213436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 107d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 786
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K213436.
Sonosite PX Ultrasound System
K213763 · FUJIFILM Sonosite, Inc. · Dec 2021
Clivia series Diagnostic Ultrasound System
K211886 · Shenzhen Wisonic Medical Technology Co. , Ltd. · Dec 2021
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
K212265 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 2021
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System
K212900 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Nov 2021
LELTEK Ultrasound Imaging System (Model: LU700 Series)
K210432 · Leltek, Inc. · Nov 2021
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
K212704 · Philips Medical Systems · Sep 2021