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 an AI/ML module.”

Algorithmartificial intelligence algorithm; AI/ML module; AI/ML/Neural Network

source quote (p.4)

“Rapid ICH uses an artificial intelligence algorithm to analyze images and highlight cases with detected ICH on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The Rapid ICH module is an AI/ML module. The Rapid ICH module is an 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 (2)

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

Bench

sample size not stated

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

Reported performance (5 observations)

sensitivity0.968CI 95% CI: 92.6% - 98.6%

source quote (p.7)

“Specifically, sensitivity was observed to be 96.8% (95% CI: 92.6% - 98.6%)”

specificity1CI 95% CI: 97.7% - 100%

source quote (p.7)

“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 95% CI 45.0-100.2

source quote (p.8)

“As shown in the table below, the predicate analysis demonstrated that standard of care time-to-exam-open (72.6 minutes: 95% CI 45.0-100.2) is significantly longer than the parallel time-to-notification of the Rapid ICH software (0.65 minutes: 95% CI 0.63 – 0.67).”

time_to_resultas written: “Time to notification of Rapid ICH (Minute)”0.65CI 95% CI 0.63 – 0.67

source quote (p.8)

“As shown in the table below, the predicate analysis demonstrated that standard of care time-to-exam-open (72.6 minutes: 95% CI 45.0-100.2) is significantly longer than the parallel time-to-notification of the Rapid ICH software (0.65 minutes: 95% CI 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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

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). 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).