InferRead CT Stroke.AI

K211179

Infervision 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, artificial intelligence algorithm
source quote (p.5)
“The software device is a computer program with a deep learning algorithm running on Ubuntu operating system. InferRead CT Stroke.AI uses an artificial intelligence algorithm to analyze images and highlight cases with detected ICH on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The subject and predicate software utilizes a deep learning algorithm trained on medical images.”
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; time-to-notification

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”1.07CI ±0.57 (mean ± SD) minutes
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”75.4CI °192.7 minutes
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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K211179