MammoScreen® (5)— 510(k) K260714

Substantially Equivalent

Therapixel

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

Clearance details

Applicant: Therapixel
Product code: 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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