Radiology AI Directory

FDA-cleared profile

Scaida BrainCT-ICH (v1.0)

Mlhealth 360

Authorized purpose: Non-contrast head CT triage for suspected intracranial hemorrhage in adults aged 22 and older.

Stroke and ICH triageAcute triage and notification
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Product overview

Start with the essentials

Authorized purpose: Non-contrast head CT triage for suspected intracranial hemorrhage in adults aged 22 and older.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Non-contrast head CT triage for suspected intracranial hemorrhage in adults aged 22 and older.

Evidence takeaway

Evidence from the reviewed source record: FDA retrospective performance study: 294 cases from three U.S. institutions, ground truth by three ABR-certified trained neuroradiologists with an experience-based tie breaker. The study included 63.9% ICH and 36.1% non-ICH cases, with two institutions independent of development data. Sensitivity was 0.867 (95% CI 0.811-0.908), specificity 0.887 (0.812-0.934), and ROC AUC 0.926. The FDA summary states clinical tests were not conducted; this was retrospective performance testing/non-clinical evidence.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Non-contrast head CT triage for suspected intracranial hemorrhage in adults aged 22 and older.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Trained radiologists.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Hospital or clinic imaging workflow for adult patients aged 22 and older.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Binary notification and worklist triage in parallel with standard of care; no queue removal and no diagnostic use of the output.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM-compliant non-contrast head CT images from adults aged 22 and older.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
A binary suspected-ICH present/not-present finding returned to a third-party worklist to alert radiologists; it does not provide ICH subtype classification and has no user interface of its own.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Not a diagnostic device; patients under 22 are excluded; unflagged or unreviewed cases remain in standard processing; the original full images require radiologist review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K250694
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Brain/Head
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-11-25
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Software-only device integrated with a third-party worklist on standard off-the-shelf or virtual server hardware; it receives DICOM analysis requests/images and returns the suspected-ICH finding. Exact local interfaces and deployment topology are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Scaida BrainCT-ICH (v1.0); FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-08
Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
FDA retrospective performance study: 294 cases from three U.S. institutions, ground truth by three ABR-certified trained neuroradiologists with an experience-based tie breaker. The study included 63.9% ICH and 36.1% non-ICH cases, with two institutions independent of development data. Sensitivity was 0.867 (95% CI 0.811-0.908), specificity 0.887 (0.812-0.934), and ROC AUC 0.926. The FDA summary states clinical tests were not conducted; this was retrospective performance testing/non-clinical evidence.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
86.7% (95% CI: 81.1%, 90.8%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

Reported specificity
88.7% (95% CI: 81.2%, 93.4%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Scaida BrainCT-ICH (v1.0) regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K250694
  • Samplen=294
  • Sites3
  • IndependenceIndependence not established

K250694

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

No public price or quote for the exact K250694 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The exact-identifier FDA recall query returned no native recall record for K250694. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-19Last searched
26Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA K250694: Scaida BrainCT-ICH (v1.0)

    U.S. Food and Drug Administration - Published 2025-11-25 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. Scaida BrainCT-ICH (v1.0) model card (K250694)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K250694

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K250694 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

Alternatives

Related tools to compare

FDA-cleared K231384

Annalise Enterprise CTB Triage Trauma

Annalise-AI Pty Ltd.

Study-level triage and prioritization notification for suspected mass effect on non-contrast brain CT in patients aged 22 years and older; not a stand-alone decision or rule-out...

Modality
CT/CTA
Anatomy
Brain/head
Decision
2023-09-22
Acute triage and notification
FDA-cleared K252421

JLK-NCCT

JLK, Inc.

Notification-only triage of adult non-contrast head CT for suspected intracranial hemorrhage and large-vessel occlusion, with parallel communication to trained clinicians during...

Modality
CT/CTA
Anatomy
Brain and intracranial vessels: intracranial hemorrhage and LVO involving ICA, MCA-M1, and MCA-M2
Decision
2026-03-24
Stroke and ICH triageAcute triage and notification
FDA-cleared K251983

Brainomix 360 Triage Stroke

Brainomix Limited

Triage and notification of suspected intracranial hemorrhage or anterior-circulation LVO on acute non-contrast head CT; not primary diagnosis.

Modality
CT/CTA
Anatomy
Brain/head, including intracranial ICA and M1 for LVO and intracranial hemorrhage findings
Decision
2025-08-26
Stroke and ICH triageAcute triage and notification