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FDA 510(k)

AI-CVD

K-Number: K252029 · 2025-12-19

ApplicantHeartLung Corporation
Decision Date2025-12-19
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI-CVD is a medical device manufactured by HeartLung Corporation. It received FDA 510(k) clearance on 2025-12-19 under approval number K252029. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AI-CVD?

AI-CVD is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by HeartLung Corporation. The 510(k) number is K252029.

When was AI-CVD approved by the FDA?

AI-CVD received FDA 510(k) clearance on 2025-12-19, under approval number K252029.

What company makes AI-CVD?

AI-CVD is manufactured by HeartLung Corporation.

What is the FDA product code for AI-CVD?

The FDA product code for AI-CVD is QIH.

Other Devices by HeartLung Corporation

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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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