Cleared Traditional

Clarius Prostate AI

K243853 · Clarius Mobile Health Corp. · Radiology
Apr 2025
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K243853 is an FDA 510(k) clearance for the Clarius Prostate 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 April 16, 2025, 121 days after receiving the submission on December 16, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K243853 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2024
Decision Date April 16, 2025
Days to Decision 121 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.