BrightHeart

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

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

Decision	Number	Device	Company	Panel
2025-12-08	K252294	Fetal EchoScan (v1.2)	Brightheart	Radiology
2025-06-05	K251456	BrightHeart View Classifier	BrightHeart	Radiology
2025-05-07	K243684	BrightHeart View Classifier	BrightHeart	Radiology
2025-05-02	K251071	Fetal EchoScan (v1.1)	BrightHeart	Radiology
2024-11-14	K242342	Fetal EchoScan	BrightHeart	Radiology

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