MammoScreen® (5)— 510(k) K260714

Name: FDA 510(k) clearance K260714
Creator: U.S. Food and Drug Administration
Published: 2026-06-26

Substantially Equivalent

Therapixel

FDA 510(k) clearance K260714 for MammoScreen® (5), Substantially Equivalent on 2026-06-26. Applicant: Therapixel. Device class: 2.

Summary

Therapixel's MammoScreen (5) is filed under QDQ, radiological computer-assisted detection and diagnosis software for lesions suspicious for cancer. The record doesn't say what the "(5)" in the name refers to.

Class II, 21 CFR 892.2090. Radiology is both the classification panel and the review panel, and it came in as a Special 510(k).

Therapixel filed from Nice, France. Review took 113 calendar days (March 5 to June 26, 2026).

Clearance details

Applicant: Therapixel
Product code: Product code QDQ
Device class: Class 2
Regulation: 21 CFR 892.2090
Advisory panel: Radiology
Date received: 2026-03-05
Decision date: 2026-06-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Nice, FR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.