Scaida BrainCT-ICH (v1.0)

K250694

Mlhealth 360 · cleared 2025-11-25 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Scaida BrainCT-ICH is a radiological computer-assisted triage and notification software device that alerts of suspected intracranial hemorrhage (ICH) condition by analyzing non-contrast CT images. The device has no user interface and is a software-only device that has no contact with the patient.”
Algorithmdeep learning algorithm
source quote (p.9)
“This study leveraged a deep learning algorithm to differentiate images containing ICH or not, using ground truth images annotated by trained neuro-radiologists, and therein provide notification from the findings.”
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)

Retrospective clinical

n=294 cases · 3 site(s)

endpoints: evaluate the software performance in identifying intracranial hemorrhage (ICH) findings

Reported performance (3 observations)

sensitivity0.867CI 95% CI: 0.811-0.908
source quote (p.10)
“The performance of Scaida BrainCT-ICH reached a sensitivity of 0.867 (95% CI: 0.811-0.908)”
specificity0.887CI 95% CI: 0.812-0.934
source quote (p.10)
“and a specificity of 0.887 (95% CI: 0.812-0.934).”
aurocas written: “auc”0.926
source quote (p.10)
“The area under the receiver operating characteristics (ROC) curve (AUC) was 0.926.”

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/K250694