Bunkerhill Abdominal Aortic Quantification (AAQ)
K243779BunkerHill Health · cleared 2025-07-01 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“Bunkerhill AAQ is a software-only medical device that employs deep learning algorithms to provide automatic maximal abdominal aortic diameter measurements from axial CT scans of the abdomen/pelvis, with or without IV contrast.”
Algorithmdeep learning algorithms
source quote (p.5)
“Bunkerhill AAQ is a software-only medical device that employs deep learning algorithms to provide automatic maximal abdominal aortic diameter measurements from axial CT scans of the abdomen/pelvis, with or without IV contrast.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (1)
Retrospective clinical
n=258 patients
endpoints: mean-absolute-error; AIСС; Bland-Altman limits
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).