Rapid Obstructive Hydrocephalus, Rapid OH

K251533

iSchemaView Inc. · cleared 2025-09-04 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Rapid OH software device is a radiological computer-aided triage and notification software device using AI/ML.”
Algorithmartificial intelligence algorithm; AI/ML module
source quote (p.6)
“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. The Rapid OH module is an AI/ML module.”
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)

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, 21 CFR, Part 820.30

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); 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/K251533