HeartFlow, Inc.

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

DecisionNumberDeviceCompanyPanel
2025-07-18K250902HeartFlow AnalysisHeartFlow, Inc.Cardiovascular
2022-10-14K213857HeartFlow AnalysisHeartFlow, Inc.Cardiovascular
2021-01-08K203329HeartFlow AnalysisHeartFlow, Inc.Cardiovascular
2019-08-15K190925HeartFlow FFRct AnalysisHeartFlow, Inc.Cardiovascular
2018-12-06K182035FFRctHeartFlow, IncCardiovascular
2016-08-24K161772FFRctHEARTFLOW, INC.Cardiovascular
2016-01-13K152733FFRctHEARTFLOW, INC.Cardiovascular

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