Therapixel

Name: AI Device Index: FDA-listed AI-enabled medical devices
Creator: AI Device Index
License: https://creativecommons.org/licenses/by/4.0/

7 AI-enabled medical devices from Therapixel on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

Decision	Number	Device	Company	Panel
2026-06-26	K260714	MammoScreen® (5)	Therapixel	Radiology
2025-08-22	K243685	MammoScreen BD	Therapixel	Radiology
2025-07-03	K243679	MammoScreen® (4)	Therapixel	Radiology
2024-10-02	K241561	MammoScreen BD	Therapixel	Radiology
2024-08-01	K240301	MammoScreen® (3)	Therapixel	Radiology
2021-11-26	K211541	MammoScreen 2.0	Therapixel	Radiology
2020-03-25	K192854	MammoScreen	Therapixel	Radiology

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