Caption Health

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

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

Decision	Number	Device	Company	Panel
2022-01-19	K210747	Caption Interpretation Automated Ejection Fraction Software	Caption Health	Radiology
2020-09-18	K201992	Caption Guidance	Caption Health	Radiology
2020-07-22	K200621	Caption Interpretation Automated Ejection Fraction Software	Caption Health	Radiology
2020-04-16	K200755	Caption Guidance	Caption Health	Radiology

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