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. The Rapid LVO module consists of the core Rapid Platform software which provides the administration and services for the Rapid image processing modules; and the Rapid LVO module which functions as one of many image processing modules hosted by the platform. SaMD: Yes - Traditional Algorithms”
AlgorithmTraditional Algorithms
source quote (p.5)
“Rapid LVO uses a software algorithm to analyze images and highlight cases with suspected LVO on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. SaMD: Yes - Traditional Algorithms”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Standalone

sample size not stated

endpoints: Sensitivity; Specificity; ROC AUC; PPV; NPV

standards: ISO 14971:2019, IEC 62304:2015, IEC 62366:2015, NEMA PS 3.1 - 3.20

Bench

sample size not stated

standards: ISO 14971:2019, IEC 62304:2015, IEC 62366:2015, NEMA PS 3.1 - 3.20

Reported performance (5 observations)

sensitivity0.97CI 95% CI: 0.933,0.987
source quote (p.7)
“Se: Sensitivity (Se) of 0.970 (95% CI: 0.933,0.987)”
specificity0.956CI 95% CI: 0.919, 0.977
source quote (p.7)
“Specificity (Sp) 0.956 (95% CI: 0.919, 0.977)”
aurocas written: “auc”0.99CI 95% CI:0.972, 0.995
source quote (p.7)
“ROC AUC of 0.99 (95% CI:0.972, 0.995)”
ppvas written: “PPV”0.95CI 95% CI: 0.90, 0.97
source quote (p.7)
“PPV = 0.95 (95% CI: 0.90, 0.97)”
npvas written: “NPV”0.98CI 95% CI 0.94, 0.99
source quote (p.7)
“NPV = 0.98 (95% CI 0.94, 0.99)”

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
2
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); 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/K200941