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FDA 510(k)

Bunkerhill Abdominal Aortic Quantification (AAQ)

K-Number: K243779 · 2025-07-01

ApplicantBunkerHill Health
Decision Date2025-07-01
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Bunkerhill Abdominal Aortic Quantification (AAQ) is the device name listed in this FDA 510(k) record. The listed applicant is BunkerHill Health. It received FDA 510(k) clearance on 2025-07-01 under 510(k) 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. The listed applicant is BunkerHill Health. The 510(k) number is K243779.

When did Bunkerhill Abdominal Aortic Quantification (AAQ) receive FDA 510(k) clearance?

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

Who is the listed applicant for Bunkerhill Abdominal Aortic Quantification (AAQ)?

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

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

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

Other records listing BunkerHill Health 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.

K260167Bunkerhill Contrast AVCK260166Bunkerhill Contrast CACK250662Bunkerhill MACK250649Bunkerhill ECG-EFK242295BunkerHill BMDK243229Bunkerhill AVC

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Related Devices (Code: QIH)

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.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, 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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