Rapid CTA 360

K251151

iSchemaView · cleared 2025-07-16 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“Rapid CTA 360 is a radiological computer aided triage and notification software indicated for use in the analysis of CTA adult head images.”

AlgorithmAI software algorithm

source quote (p.4)

“Rapid CTA 360 uses an AI software algorithm to analyze images and highlight cases with suspected occlusion on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedYes

source quote (p.9)

“iSchemaView uses the OWASP vulnerability risk process to identify and mitigate cybersecurity risks in conjunction with internal and external periodic assessments. iSchemaView maintains a compliance framework as annually certified by ISO 27001/27701 and conformance with UL-2900-1 through integrated development processes including: SBOM management, Penetration Testing, DAST and lifecycle monitoring.”

Validation studies (2)

Retrospective clinical

n=6,264 cases · 133 site(s)

Standalone

n=403 cases

endpoints: primary endpoint analysis; secondary endpoint analysis showed time to notification

standards: EN ISO 14971:2019 (R2021), IEC 62304:2006 (R2015), IEC 62366:2015 (R2020), NEMA PS 3.1 - 3.20, UL 2900-1 (2017)

Reported performance (3 observations)

sensitivity0.921CI 95% CI: 0.880, 0.949

source quote (p.8)

“The primary endpoint analysis passed with Sensitivity 0.921 (95% CI: 0.880, 0.949) and Specificity 0.890 (95% CI: 0.832, 0.929) supporting the finding.”

specificity0.89CI 95% CI: 0.832, 0.929

source quote (p.8)

“The primary endpoint analysis passed with Sensitivity 0.921 (95% CI: 0.880, 0.949) and Specificity 0.890 (95% CI: 0.832, 0.929) supporting the finding.”

time_to_resultas written: “time to notification”3.2CI min:1.92 min to 5.35min

source quote (p.8)

“A secondary endpoint analysis showed time to notification of 3.2 minutes, min:1.92 min to 5.35min.”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

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).