Rapid ICH

K221456

iSchemaView Inc. · cleared 2022-09-12 · product code QAS · Radiology

FDA 510(k) summary for Rapid ICH (K221456)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
1
Performance observations
5
Product code
QAS
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Rapid ICH is a radiological computer-assisted triage and notification software device. The Rapid ICH module is a non-enhanced CT (NCCT) processing module which operates within the integrated Rapid Platform to provide triage and notification prioritization of suspected intracranial hemorrhage. The Rapid ICH module is an AI/ML module.”
AlgorithmAI/ML/Neural Network
source quote (p.4)
“The Rapid ICH module is an AI/ML module.”
Adaptive (vs locked)No
source quote (p.5)
“The minor change causing this filing, is the use of additional data for training and validation; there are no further differences.”
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=314 cases

endpoints: evaluate the software's performance in identifying NCCT head images containing intracranial hemorrhage (ICH) findings

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

Reported performance (5 observations)

sensitivity0.968CI 92.6% - 98.6%
source quote (p.7)
“Specifically, sensitivity was observed to be 96.8% (95% CI: 92.6% - 98.6%)”
specificity1CI 97.7% - 100%
source quote (p.7)
“and specificity was observed to be 100% (95% CI: 97.7% - 100%) overall.”
aurocas written: “auc”0.98632
source quote (p.7)
“AUC is 0.98632 when using Rapid estimated Volume as the predictor of Suspected ICH”
time_to_resultas written: “Time to open in standard of care (Minutes)”72.58CI 45.02-100.14
source quote (p.8)
“Time to open in standard of care (Minutes) 72.58 45.02 100.14”
time_to_resultas written: “Time to notification of Rapid ICH (Minute)”0.65CI 0.63-0.67
source quote (p.8)
“Time to notification of Rapid ICH (Minute) 0.65 0.63 0.67”

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
  • predicate_cohort_contagion

    K221456 shares predicate K193087 with K233512 (Rapid (6.0)), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-08-26 · predicate:K193087 sibling:K233512

  • 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 2026-08-26.

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.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K221456