Rapid ICH

K221456

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

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
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/K221456