Rapid LVO
K221248iSchemaView Inc. · cleared 2022-05-31 · product code QAS · Radiology
Premarket evidence — what FDA accepted
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.”
source quote (p.5)
“The LVO module uses traditional programming algorithms.”
Validation studies (1)
Standalone
n=217 scans · 8 site(s)
endpoints: Sensitivity; Specificity; PPV; NPV; AUC
standards: ISO 14971:2019, IEC 62304:2015, IEC 62366:2015, NEMA PS 3.1 - 3.20
Reported performance (6 observations)
source quote (p.8)
“The observed results are Se: 0.96 (95% CI: 0.91 -0.97)”
source quote (p.8)
“and Sp: 0.98 (95% CI: 0.93-0.99)”
source quote (p.8)
“The RoC AUC is 0.99”
source quote (p.8)
“Additionally, PPV = 0.98 and NPV = 0.96.”
source quote (p.8)
“Additionally, PPV = 0.98 and NPV = 0.96.”
source quote (p.8)
“In addition, an analysis on time to notification using Rapid LVO to notify of suspicion/non-suspicion as 3.18 min (95% CI: 3.11 – 3.25) was achieved meeting the goal of ≤ 3.5min established by the predicate.”
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
- 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).