Accipiolx
K182177MaxQ-Al Ltd. · cleared 2018-10-26 · product code QAS · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.4)
“Accipiolx is a software device designed to be installed within healthcare facility radiology networks to identify and prioritize non-contrast head CT (NCCT) scans based on algorithmically-identified findings of acute intracranial hemorrhage (aICH).”
Algorithmcomputer vision and deep learning technologies, artificial intelligence algorithm
source quote (p.4)
“The device, developed using computer vision and deep learning technologies, facilitates prioritization of CT scans containing findings of aICH. Accipiolx analyzes cases using an artificial intelligence algorithm to identify suspected findings.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo
Validation studies (1)
Retrospective clinical
n=360 cases · 30 site(s)
endpoints: sensitivity; specificity
Reported performance (2 observations)
sensitivity0.92CI 95% CI: 87.29-95.68%
source quote (p.6)
“Analysis of 360 cases collected from over 30 US sites demonstrated system sensitivity and specificity of 92% (95% CI: 87.29-95.68%) and 86% (95% CI: 80.18-90.81%), respectively.”
specificity0.86CI 95% CI: 80.18-90.81%
source quote (p.6)
“Analysis of 360 cases collected from over 30 US sites demonstrated system sensitivity and specificity of 92% (95% CI: 87.29-95.68%) and 86% (95% CI: 80.18-90.81%), respectively.”
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).