Rapid Aneurysm Triage and Notification

K230074

iSchemaView Inc. · cleared 2023-07-27 · product code QFM · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“Rapid Aneurysm Triage and Notification (ANRTN) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head.”

Algorithmartificial intelligence algorithm

source quote (p.3)

“Rapid ANRTN uses an artificial intelligence algorithm to analyze images and highlight studies with suspected saccular aneurysms in a standalone application for study list prioritization or triage in parallel to ongoing standard of care.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.11)

“Rapid ANRTN has been developed using the cybersecurity framework defined within the FDA Draft Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”

Validation studies (1)

Standalone

n=266 cases

endpoints: AUC ">= 0.95 for high performance

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

Reported performance (2 observations)

sensitivity0.933

source quote (p.9)

“Additionally, Sensitivity (0.933) and Specificity(0.868) supported the finding.”

specificity0.868

source quote (p.9)

“Additionally, Sensitivity (0.933) and Specificity(0.868) supported the finding.”

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

re_clearance
The FDA AI/ML device list shows a newer 510(k) K233512 (decision 2024-01-16) from iSchemaView, Inc. for a matching device line ("Rapid (6.0)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K233512

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).