Rapid Obstructive Hydrocephalus, Rapid OH
K251533iSchemaView Inc. · cleared 2025-09-04 · product code QAS · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“The Rapid OH device is SaMD which analyzes input NCCT images that are provided in DICOM format for notification of suspected findings for workflow prioritization.”
Algorithmartificial intelligence algorithm / AI/ML module
source quote (p.4)
“Rapid OH uses an artificial intelligence algorithm to analyze images and highlight cases with suspected OH on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo
Validation studies (1)
Standalone
n=320 cases
endpoints: sensitivity; specificity; time to notification
standards: EN ISO 14971:2019 (R2021), IEC 62304:2006 (R2015), IEC 62366:2015 (R2020), NEMA PS 3.1 - 3.20
Reported performance (3 observations)
sensitivity0.895CI 95% CI:0.837-0.935
source quote (p.9)
“Standalone performance primary endpoint passed with sensitivity (Se) of 89.5% (95% CI:0.837-0.935)”
specificity0.976CI 95% CI:0.940-0.991
source quote (p.9)
“and specificity (Sp) of 97.6% (95% CI:0.940-0.991)”
time_to_resultas written: “time to notification”30.3CI range 10.5-55.5 seconds
source quote (p.9)
“the secondary endpoint demonstrated time to notification time of 30.3 seconds (range 10.5-55.5 seconds).”
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
0
drift signals on this device
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).