# K243779: Bunkerhill Abdominal Aortic Quantification (AAQ)

- Pathway: 510(k) (Traditional)
- Applicant: BunkerHill Health
- Decided: Jul 1, 2025 after 204 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K945512 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230534: BriefCase-Quantification, Aidoc Medical, Ltd. (2023) Summary page 5.

## Indications for use
Bunkerhill AAQ is a radiological image processing system software indicated for use in the analysis of CT exams with or without contrast, that include the L1 — L5 region of the abdominal aorta, in adults aged 22 and older. The device is intended to assist appropriately trained medical specialists by providing the user with the maximum axial abdominal aortic axial diameter measurement of cases that include the abdominal aorta. Bunkerhill AAQ is indicated to evaluate normal and aneurysmal abdominal aortas and is not intended to evaluate post-operative aortas. The Bunkerhill AAQ results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. These measurements are unofficial, are not final, and are subject to change after review by a qualified interpreting physician. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing full images per the standard of care.

Source page: https://510kreport.com/device/K243779
Methodology: https://510kreport.com/methodology