Cleared Traditional

MammoScreen BD

K243685 · Therapixel · Radiology
Aug 2025
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K243685 is an FDA 510(k) clearance for the MammoScreen BD, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Therapixel (Nice, FR). The FDA issued a Cleared decision on August 22, 2025, 266 days after receiving the submission on November 29, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K243685 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2024
Decision Date August 22, 2025
Days to Decision 266 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.