FDA-cleared profile

Annalise Enterprise CTB Triage Trauma

Annalise-AI Pty Ltd

Intended Context Annalise Triage is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of the following findings: Chest X-ray (CXR) • pleural effusion 1 • pneumoperitoneum 2 • pneumothorax • tension pneumothorax CT brain (CTB) • acute subdural/epidural hematoma 3 • acute subarachnoid hemorhage 3 • intra-axial hemorrhage 3 • intraventricular hemorrhage 3 • mass effect • obstructive hydrocephalus • vasogenic edema See additional information below The device analyzes studies using an artificial intelligence algorithm to identify findings. It makes study-level output available to an order and imaging management system for worklist prioritization or triage. The device is not intended to direct attention to specific portions of an image and only provides notification for suspected findings. Its results are not intended: • to be used on a standalone basis for clinical decision making • to rule out specific findings, or otherwise preclude clinical assessment of CXR or CTB studies Intended Modality Annalise Triage identifies suspected findings in Chest X-ray (CXR) • Digitized (CR) or digital (DX) chest X-ray studies CT brain (CTB) • Non-contrast brain CT studies Intended User The device is intended to be used by trained clinicians who are qualified to interpret chest X-ray studies (for chest X-ray findings) and brain CT studies (for brain CT findings) as part of their scope of practice. Intended Patient Population The intended population is patients who are 22 years or older. Additional Information The following additional information relates to the finding listed above: 1 Pleural effusion: • specificity may be reduced in the presence of scarring and/or pleural thickening • standalone performance evaluation was performed on a dataset that included supine and erect positioning • use of this device with prone positioning may result in differences in performance 2 Pneumoperitoneum • standalone performance evaluation was performed on a dataset that included supine and erect positioning where most cases were of unilateral right-sided and bilateral pneumoperitoneum • use of this device with prone positioning and for unilateral left-sided pneumoperitoneum may result in differences in performance 3 Acute subdural/epidural hematoma, acute subarachnoid hemorrhage, intra-axial hemorrhage and intraventricular hemorrhage • intended to be used together as one device

Detection and CADe Acute triage and notification Stroke and ICH triage Chest CT

Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.

Clinical fit

What this tool is for

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

Exact purpose: Intended Context Annalise Triage is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of the following findings: Chest X-ray (CXR) • pleural effusion 1 • pneumoperitoneum 2 • pneumothorax • tension pneumothorax CT brain (CTB) • acute subdural/epidural hematoma 3 • acute subarachnoid hemorhage 3 • intra-axial hemorrhage 3 • intraventricular hemorrhage 3 • mass effect • obstructive hydrocephalus • vasogenic edema See additional information below The device analyzes studies using an artificial intelligence algorithm to identify findings. It makes study-level output available to an order and imaging management system for worklist prioritization or triage. The device is not intended to direct attention to specific portions of an image and only provides notification for suspected findings. Its results are not intended: • to be used on a standalone basis for clinical decision making • to rule out specific findings, or otherwise preclude clinical assessment of CXR or CTB studies Intended Modality Annalise Triage identifies suspected findings in Chest X-ray (CXR) • Digitized (CR) or digital (DX) chest X-ray studies CT brain (CTB) • Non-contrast brain CT studies Intended User The device is intended to be used by trained clinicians who are qualified to interpret chest X-ray studies (for chest X-ray findings) and brain CT studies (for brain CT findings) as part of their scope of practice. Intended Patient Population The intended population is patients who are 22 years or older. Additional Information The following additional information relates to the finding listed above: 1 Pleural effusion: • specificity may be reduced in the presence of scarring and/or pleural thickening • standalone performance evaluation was performed on a dataset that included supine and erect positioning • use of this device with prone positioning may result in differences in performance 2 Pneumoperitoneum • standalone performance evaluation was performed on a dataset that included supine and erect positioning where most cases were of unilateral right-sided and bilateral pneumoperitoneum • use of this device with prone positioning and for unilateral left-sided pneumoperitoneum may result in differences in performance 3 Acute subdural/epidural hematoma, acute subarachnoid hemorrhage, intra-axial hemorrhage and intraventricular hemorrhage • intended to be used together as one device

Intended users: The device is intended to be used by trained clinicians who are qualified to interpret chest X-rays (for chest x-ray findings) and brain CT studies (for brain CT findings) as part of their scope of practice.

Care setting and population: Adult

Workflow role: Triage or notification support

Required input: CT images or data. Inclusion criteria: Annalise Triage supports the following scan types: CXR • minimum one frontal (AP/PA) required for processing* • up to three images in total • lateral (LAT) is also supported Note: If a study contains more than three CXR images, the AI model will select a combination of the best three frontal/lateral images. CTB • axial (coronal and sagittal views are generated by the axial view) • slice thickness up to and including 5mm • non-contrast brain CT scans • brain reconstruction kernel (or similar) • up to 1,000 images

Output and human action: The device analyzes studies using an artificial intelligence algorithm to identify findings. It makes study-level output available to an order and imaging management system for worklist prioritization or triage.

Limitations: Exclusion criteria: NA. Supported hardware: Unspecified. Scanner manufacturers: All

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

Modality: CT/CTA

Anatomy: Chest/Lung

Clearance type: 510(k)

Decision date: 2023-04-03

FDA status: FDA-cleared

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.

Deployment and data flow: On-premise

Security and privacy: Vendor documentation pending

Training and support: Vendor documentation pending

Monitoring and change control: Vendor documentation pending

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

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.

Evidence summary: Study type: Stand-Alone Performance. Cases: 3363. Reference standard: Interpretation by Reviewing Clinician. 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%). 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%). Additional reported metrics: Model Sensitivity >1.5mm to ≤5.0mm: Acute subdural/epidural hematoma - 82.4 (78.6,86.1) Acute subarachnoid hemorrhage - 90.7 (86.3,95.1) Intra-axial hemorrhage - 93.4 (91.3,95.1) Intraventricular hemorrhage- 87.9 (80.2,94.5) Model Specificity >1.5mm to ≤5.0mm: Acute subdural/epidural hematoma - 89.6 (83.7,94.8) Acute subarachnoid hemorrhage - 92.4 (86.7,97.1) Intra-axial hemorrhage - 85.1 (80.9,88.9) Intraventricular hemorrhage- 97.8 (94.6,100.0) Performance assessed at multiple operating points, refer to Performance Guide

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%)

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%)

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

Stand-Alone Performance · Adult

exact submission · Tested version: 3.3+ · n=3363 · Independence not established

K223240

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

Source

Economics and lifecycle

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

Reimbursement and coding: Research pending

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: Not established in reviewed sources

Buyer worksheet

Open questions to take to the vendor

Verify security and privacy controls: FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Verify pricing and total cost: FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

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

2026-09-04Last searched

20Fields reviewed

6Source classes checked

0Unreviewed PubMed leads

0Unreviewed trial leads

0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

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

Sources

Source ledger

Sources accessed through 2026-09-02.

K223240 FDA decision source U.S. Food and Drug Administration · 2026-08-31
Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
Annalise CTB - Intracranial Hemorrhage model card (K223240) American College of Radiology · 2026-09-01
PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02

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