FDA 510(k)

AI-CVD

K-Number: K252029 · 2025-12-19

Decision Date2025-12-19

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AI-CVD is the device name listed in this FDA 510(k) record. The listed applicant is HeartLung Corporation. It received FDA 510(k) clearance on 2025-12-19 under 510(k) 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. The listed applicant is HeartLung Corporation. The 510(k) number is K252029.

When did AI-CVD receive FDA 510(k) clearance?

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

Who is the listed applicant for AI-CVD?

The FDA 510(k) record lists HeartLung Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AI-CVD?

The FDA product code for AI-CVD is QIH.

Other records listing HeartLung Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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