InferRead CT Stroke.AI
K211179Infervision Medical Technology Co., Ltd. · cleared 2021-08-12 · product code QAS · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“InferRead CT Stroke.AI is a radiological computer-assisted triage and notification software device. The software device is a computer program with a deep learning algorithm running on Ubuntu operating system.”
Algorithmdeep learning algorithm
source quote (p.5)
“The software device is a computer program with a deep learning algorithm running on Ubuntu operating system.”
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=369 scans · 3 site(s)
endpoints: sensitivity; specificity; AUC; InferRead time-to-notification; standard of care time-to-open-exam
Reported performance (5 observations)
sensitivity0.916CI 95% CI: 0.867-0.951
source quote (p.10)
“Comparing the InferRead software output to the ground truth, the sensitivity and specificity of InferRead CT Stroke.AI are 0.916 (95% CI: 0.867-0.951) and 0.922 (95% CI: 0.872-0.957), which are significantly higher than the 80% null hypothesis (p values < 0.001).”
specificity0.922CI 95% CI: 0.872-0.957
source quote (p.10)
“Comparing the InferRead software output to the ground truth, the sensitivity and specificity of InferRead CT Stroke.AI are 0.916 (95% CI: 0.867-0.951) and 0.922 (95% CI: 0.872-0.957), which are significantly higher than the 80% null hypothesis (p values < 0.001).”
aurocas written: “auc”0.962
source quote (p.10)
“In addition, the area under the receiver operating characteristic curve (AUC) was 0.962, demonstrating the clinical utility and potential benefits of the InferRead software based on the imaging study results.”
time_to_resultas written: “InferRead time-to-notification”1.07
source quote (p.10)
“The InferRead time-to-notification is 1.07 ±0.57 (mean ± SD) minutes, which is substantially lower than the standard of care time-to-open-exam of 75.4°192.7 minutes (P < 0.001).”
time_to_resultas written: “standard of care time-to-open-exam”75.4
source quote (p.10)
“The InferRead time-to-notification is 1.07 ±0.57 (mean ± SD) minutes, which is substantially lower than the standard of care time-to-open-exam of 75.4°192.7 minutes (P < 0.001).”
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).