Rapid NCCT Stroke

K222884

iSchemaView, Inc. · cleared 2023-03-02 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The RNS is an AI/ML SaMD.”
Algorithmartificial intelligence algorithm; AI/ML SaMD; ICH Algorithm; ASPECTS and Hyperdense Vessel Sign (HVS) algorithms; AI/ML/Neural Network
source quote (p.3)
“Rapid NCCT Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) ICH or (2) NCCT LVO on the Rapid server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The RNS is an AI/ML SaMD. The output of the module is a priority notification to clinicians indicating the suspicion of ICH or NCCT LVO. ICH analysis uses the ICH Algorithm to identify findings within the ICH algorithm; and the NCCT LVO suspicion uses the combined analysis of the ASPECTS and Hyperdense Vessel Sign (HVS) algorithms. AI/ML/Neural Network”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=254 cases

endpoints: evaluate the software's performance in identifying NCCT head images containing intracranial hemorrhage (ICH) and large vessel occlusion (LVO) findings; secondary clinical endpoints were used to show expert non-inferiority and non-expert superiority

standards: EN ISO 14971:2012, IEC 62304:2015, NEMA PS 3.1 - 3.20

Reported performance (8 observations)

sensitivity0.635CI 0.544 - 0.717
source quote (p.9)
“LVO was observed at Se:0.635 (95% CI: 0.544 - 0.717)”
specificity0.951CI 0.891 – 0.979
source quote (p.9)
“Sp: 0.951 (95% CI: 0.891 – 0.979).”
sensitivityas written: “ICH Sensitivity”0.962
source quote (p.9)
“ICH performance was observed at Se:0.962”
specificityas written: “ICH Specificity”0.974
source quote (p.9)
“Sp:0.974”
sensitivityas written: “Sensitivity for all readers (experts and non-experts)”0.436
source quote (p.9)
“Se for all readers (experts and non-experts) of 0.436”
sensitivityas written: “Difference in Sensitivity between NCCT Stroke and all readers”0.199CI 0.055-0.34
source quote (p.9)
“difference in Se between NCCT Stroke and all readers of 0.199(95%CI: 0.055-0.34)”
sensitivityas written: “Sensitivity for general radiologists”0.409
source quote (p.9)
“Se for general radiologists of 0.409”
sensitivityas written: “Difference in Sensitivity between NCCT Stroke and general radiologists”0.226CI 0.071-0.381
source quote (p.9)
“difference in Se of 0.226(95%CI: 0.071-0.381)”

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
1
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); 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/K222884