Cleared Traditional

Clarius Ejection Fraction AI

K253593 · Clarius Mobile Health Corp. · Radiology
Mar 2026
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K253593 is an FDA 510(k) clearance for the Clarius Ejection Fraction AI, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Clarius Mobile Health Corp. (Vancouver, CA). The FDA issued a Cleared decision on March 2, 2026, 105 days after receiving the submission on November 17, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K253593 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2025
Decision Date March 02, 2026
Days to Decision 105 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QIH — Automated Radiological Image Processing Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.