Radiology AI Directory

FDA-cleared profile

Annalise Enterprise CTB Triage Trauma

Annalise-AI Pty Ltd

Authorized purpose: Triage and prioritization of adult CTB studies suggestive of acute subdural/epidural hematoma, acute subarachnoid hemorrhage, intra-axial hemorrhage, or intraventricular hemorrhage; the findings are intended to be used together.

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: Triage and prioritization of adult CTB studies suggestive of acute subdural/epidural hematoma, acute subarachnoid hemorrhage, intra-axial hemorrhage, or intraventricular hemorrhage; the findings are intended to be used together.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Triage and prioritization of adult CTB studies suggestive of acute subdural/epidural hematoma, acute subarachnoid hemorrhage, intra-axial hemorrhage, or intraventricular hemorrhage; the findings are intended to be used together.

Evidence takeaway

Evidence from the reviewed source record: FDA packet reports retrospective standalone testing from five US hospital-network sites: 1,485 cases at slice thickness <=1.5 mm and 1,878 cases at >1.5 mm to <=5.0 mm, with finding-, slice-thickness-, and operating-point-specific sensitivity and specificity tables.

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
Triage and prioritization of adult CTB studies suggestive of acute subdural/epidural hematoma, acute subarachnoid hemorrhage, intra-axial hemorrhage, or intraventricular hemorrhage; the findings are intended to be used together.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled in this remediation finding.

Intended users
Trained clinicians qualified to interpret brain CT studies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Care setting and population
Adult
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.

Workflow role
Triage or notification support
  • Public source
  • Exact FDA submission
  • Checked 2026-08-31

Conservative normalization of explicit wording in an exact-submission source.

Required input
Adult DICOM non-contrast brain CT studies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Output and human action
Study-level notification to an order and imaging-management system for worklist prioritization or triage; notification only, without image localization.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Limitations
Patients age 22 or older; not standalone; not a rule-out device and not intended to preclude clinical assessment of CTB studies; the four hemorrhage findings are intended to be used together.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

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
K223240
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Anatomy
Brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-04-03
  • 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
Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.

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 2026-09-09

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 2026-09-09

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 2026-09-09

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

Supported acquisition environment

Supported hardware: Unspecified. Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Annalise Enterprise CTB Triage Trauma; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-09
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 packet reports retrospective standalone testing from five US hospital-network sites: 1,485 cases at slice thickness <=1.5 mm and 1,878 cases at >1.5 mm to <=5.0 mm, with finding-, slice-thickness-, and operating-point-specific sensitivity and specificity tables.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Reported sensitivity
<=1.5mm: Acute subdural/epidural hematoma - 91.4% (95% CI: 88.1%, 94.4%) Acute subarachnoid hemorrhage - 93.9% (95% CI: 89.8%, 97.3%) Intra-axial hemorrhage - 93.1% (95% CI: 90.8%, 95.2%) Intraventricular hemorrhage - 90.4% (95% CI: 83.6%, 97.3%)
  • 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
<=1.5mm: Acute subdural/epidural hematoma - 86.7% (95% CI: 79.6%, 92.9%) Acute subarachnoid hemorrhage - 96.5% (95% CI: 91.8%, 100.0%) Intra-axial hemorrhage - 85.6% (95% CI: 81.1%, 89.6%) Intraventricular hemorrhage - 97.4% (95% CI: 93.5%, 100.0%)
  • 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.

Annalise CTB - Intracranial Hemorrhage regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested version3.3+
  • Samplen=3363
  • IndependenceIndependence not established

K223240

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 2026-09-09

No public price or quote for the exact K223240 configuration was established in this review.

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

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 K223240. 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 2026-09-09

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
2026-09-20Last searched
28Fields reviewed
10Source 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, fda decision summary packet, 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 K223240: Annalise Enterprise CTB Triage Trauma

    U.S. Food and Drug Administration - Published 2023-04-03 - Accessed 2026-09-19

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Annalise CTB - Intracranial Hemorrhage model card (K223240)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, 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 K223240

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

    Scope: postmarketSafety

Research history

  1. K223240 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

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