Rapid LVO

K200941

iSchemaView Inc. · cleared 2020-07-09 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

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

AlgorithmTraditional Algorithms

source quote (p.10)

“Yes - Traditional Algorithms”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.6)

“In particular, Rapid uses a SMTP protocol with security extensions to provide secure emailing. It supports secure VPN (Virtual Private Network) networking or encapsulated Secure Shell (SSH), and seamlessly integrates into an existing radiological data network.”

Validation studies (2)

Standalone

sample size not stated

endpoints: Sensitivity; Specificity; ROC AUC; PPV; NPV; Time to notification

standards: ISO 14971:2019, IEC 62304:2015, IEC 62366:2015, NEMA PS 3.1 - 3.20, 21 CFR, Part 820.30

Bench

sample size not stated

standards: ISO 14971:2019, 21 CFR, Part 820.30

Reported performance (6 observations)

sensitivity0.97CI 0.933,0.987

source quote (p.7)

“Sensitivity (Se) of 0.970 (95% CI: 0.933,0.987)”

specificity0.956CI 0.919, 0.977

source quote (p.7)

“Specificity (Sp) 0.956 (95% CI: 0.919, 0.977)”

aurocas written: “auc”0.99CI 0.972, 0.995

source quote (p.7)

“ROC AUC of 0.99 (95% CI:0.972, 0.995)”

ppvas written: “PPV”0.95CI 0.90, 0.97

source quote (p.7)

“PPV = 0.95 (95% CI: 0.90, 0.97)”

npvas written: “NPV”0.98CI 0.94, 0.99

source quote (p.7)

“NPV = 0.98 (95% CI 0.94, 0.99)”

time_to_resultas written: “Time to notification (min)”2.86CI 2.79, 2.92

source quote (p.7)

“an analysis on time to notification using Rapid LVO to notify of suspicion/non-suspicion as 2.86 min (95% CI: 2.79, 2.92)”

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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K221248 (decision 2022-05-31) from iSchemaView Inc. for a matching device line ("Rapid LVO") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K221248

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).