StrokeSENS LVO
K212261Circle Neurovascular Imaging, Inc · cleared 2021-10-14 · product code QAS · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.4)
“StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images.”
AlgorithmArtificial Intelligence / Machine Learning
source quote (p.9)
“Artificial Intelligence / Machine Learning”
Adaptive (vs locked)No
source quote (p.9)
“Algorithms are static and locked. Algorithms are not dynamic or learning while in the market.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.10)
“Verification and validation testing were conducted to ensure specifications and performance of the device and were performed per the FDA Guidance documents “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices".”
Validation studies (1)
Retrospective clinical
n=400 cases
endpoints: sensitivity; specificity; time to notify
standards: ISO 13485:2016, IEC 62304:2015, IEC 62366:2015, ISO 14971:2019, NEMA 3.1-3.20 (2011)
Reported performance (2 observations)
sensitivity89.4CI 95% CI = [85.3%, 93.5%]
source quote (p.10)
“The device achieved a mean sensitivity of 89.4% CI = [85.3%, 93.5%]”
specificity87.4CI 95% CI = [82.6%, 92.2%]
source quote (p.10)
“and mean specificity of 87.4% CI = [82.6%, 92.2%]”
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).