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HeartFlow, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250902HeartFlow AnalysisJuly 18, 2025
K213857HeartFlow AnalysisOctober 14, 2022
K203329HeartFlow AnalysisJanuary 8, 2021
K190925HeartFlow FFRct AnalysisAugust 15, 2019
K182035FFRctDecember 6, 2018
K161772FFRctAugust 24, 2016
K152733FFRctJanuary 13, 2016
DEN130045HEARTFLOW FFRCTNovember 26, 2014