Rapid SDH

K232436

iSchemaView, Inc. · cleared 2023-10-25 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Rapid SDH is a radiological computer aided triage and notification software indicated for use in the triage and notification of hemispheric SDH in non-enhanced head images.”
Algorithmartificial intelligence algorithm
source quote (p.7)
“Rapid SDH uses an artificial intelligence algorithm to analyze images and highlight cases with suspected hemispheric SDH 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
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.10)
“Rapid has been designed to meet the cybersecurity requirements using design Vulnerability Assessments, SBOM's, and PEN Testing.”

Validation studies (1)

Retrospective clinical

n=310 cases · 14 site(s)

endpoints: evaluate the software's performance in identifying CT scans containing sub-dural intracranial hemorrhage (SDH)

standards: ISO 14971:2019, IEC 62304:2015, IEC 62366:2015, NEMA PS 3.1 - 3.20, EN ISO 14971:2012, ISO 62304:2015

Reported performance (3 observations)

sensitivity0.924CI 0.871 – 0.956
source quote (p.10)
“Sensitivity (Se) was measured at Se: 0.924 (95% CI: 0.871 – 0.956)”
specificity0.987CI 0.95477 – 0.996
source quote (p.10)
“Sp: 0.987 (95% CI: 95477 – 0.996)”
aurocas written: “auc”0.995CI 0.986, 1.0
source quote (p.10)
“The RoC/AUC analysis using Rapid SDH Volume estimate as a predictor of Suspected SDH is AUC: 0.995 (0.986, 1.0)”

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/K232436