FDA 510(k)

Bunkerhill Abdominal Aortic Quantification (AAQ)

K-Number: K243779 · 2025-07-01

Decision Date2025-07-01

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Bunkerhill Abdominal Aortic Quantification (AAQ) is a medical device manufactured by BunkerHill Health. It received FDA 510(k) clearance on 2025-07-01 under approval number K243779. 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 Bunkerhill Abdominal Aortic Quantification (AAQ)?

Bunkerhill Abdominal Aortic Quantification (AAQ) is a medical device that received FDA 510(k) clearance on 2025-07-01. It is manufactured by BunkerHill Health. The 510(k) number is K243779.

When was Bunkerhill Abdominal Aortic Quantification (AAQ) approved by the FDA?

Bunkerhill Abdominal Aortic Quantification (AAQ) received FDA 510(k) clearance on 2025-07-01, under approval number K243779.

What company makes Bunkerhill Abdominal Aortic Quantification (AAQ)?

Bunkerhill Abdominal Aortic Quantification (AAQ) is manufactured by BunkerHill Health.

What is the FDA product code for Bunkerhill Abdominal Aortic Quantification (AAQ)?

The FDA product code for Bunkerhill Abdominal Aortic Quantification (AAQ) is QIH.

Related Clinical Trials

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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.