a2z-Unified-Triage
K252366A2z Radiology Ai, Inc. · cleared 2025-11-24 · product code QAS · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.7)
“SaMD (Software as a Medical Device)”
AlgorithmNon-adaptive machine learning (Deep Learning Neural Networks)
source quote (p.8)
“Non-adaptive machine learning (Deep Learning Neural Networks)”
Adaptive (vs locked)No
source quote (p.13)
“The PCCP does not include provisions for implementation of adaptive algorithms that will continuously learn in the field.”
PCCPYes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedFDA source did not state this
Validation studies (1)
Standalone
n=675 cases · 12 site(s)
endpoints: accuracy of detecting the 7 findings against a reference standard established by U.S. board-certified radiologists; sensitivity; specificity; AUC
Reported performance (5 observations)
aurocas written: “Acute Cholecystitis AUC”0.985CI 0.972-0.998
source quote (p.12)
“AUC: 0.985 [0.972-0.998]”
aurocas written: “Acute Pancreatitis AUC”0.994CI 0.985-1.000
source quote (p.12)
“AUC: 0.994 [0.985-1.000]”
aurocas written: “Acute Diverticulitis AUC”0.995CI 0.990-1.000
source quote (p.12)
“AUC: 0.995 [0.990-1.000]”
aurocas written: “Unruptured AAA AUC”0.995CI 0.991-0.999
source quote (p.12)
“AUC: 0.995 [0.991-0.999]”
aurocas written: “Hydronephrosis AUC”0.976CI 0.960-0.991
source quote (p.12)
“AUC: 0.976 [0.960-0.991]”
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
0
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).