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FDA 510(k)

HeartFlow Analysis

K-Number: K250902 · 2025-07-18

ApplicantHeartFlow, Inc.
Decision Date2025-07-18
Product CodePJA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HeartFlow Analysis is a medical device manufactured by HeartFlow, Inc.. It received FDA 510(k) clearance on 2025-07-18 under approval number K250902. The device is classified under product code PJA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HeartFlow Analysis?

HeartFlow Analysis is a medical device that received FDA 510(k) clearance on 2025-07-18. It is manufactured by HeartFlow, Inc.. The 510(k) number is K250902.

When was HeartFlow Analysis approved by the FDA?

HeartFlow Analysis received FDA 510(k) clearance on 2025-07-18, under approval number K250902.

What company makes HeartFlow Analysis?

HeartFlow Analysis is manufactured by HeartFlow, Inc..

What is the FDA product code for HeartFlow Analysis?

The FDA product code for HeartFlow Analysis is PJA.

Other Devices by HeartFlow, Inc.

K161772FFRct K152733FFRct K182035FFRct K190925HeartFlow FFRct Analysis K203329HeartFlow Analysis K213857HeartFlow Analysis

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Related Devices (Code: PJA)

K161772FFRctHeartFlow, Inc. K152733FFRctHeartFlow, Inc. K182035FFRctHeartFlow, Inc. K190925HeartFlow FFRct AnalysisHeartFlow, Inc. K203329HeartFlow AnalysisHeartFlow, Inc. K213857HeartFlow AnalysisHeartFlow, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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