Supported acquisition environment
Supported hardware: Unspecified. Scanner manufacturers: All
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
FDA-cleared profile
Annalise Enterprise CXR 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) • vertebral compression fracture 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 studies Intended Modality Annalise Triage identifies suspected findings in Chest X-ray (CXR) • Digitized (CR) or digital (DX) chest X-ray studies Intended User The device is intended to be used by trained clinicians who are qualified to interpret chest X-ray studies 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 Vertebral compression fracture: • intended for clinicians in Bone Health and Fracture Liaison service programs • standalone performance evaluation was performed on a dataset that included only erect positioning • use of this device with supine positioning may result in differences in performance
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.
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
- 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) • vertebral compression fracture 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 studies Intended Modality Annalise Triage identifies suspected findings in Chest X-ray (CXR) • Digitized (CR) or digital (DX) chest X-ray studies Intended User The device is intended to be used by trained clinicians who are qualified to interpret chest X-ray studies 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 Vertebral compression fracture: • intended for clinicians in Bone Health and Fracture Liaison service programs • standalone performance evaluation was performed on a dataset that included only erect positioning • use of this device with supine positioning may result in differences in performance
Clinical-use display mirrors the best exact-submission purpose source because the reviewed FDA packet did not provide a more specific usable abstraction.
- Intended users
- The device is intended to be used by trained clinicians who are qualified to interpret chest X-ray studies as part of their scope of practice.
Intended-user text reported in the exact-submission ACR model card.
- Care setting and population
- Adult
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Triage or notification support
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- X-ray/Radiography images or data involving Chest/Lung; consult the FDA labeling for exact protocol, series, and quality requirements.
Conservative normalization of explicit wording in an exact-submission source.
- 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.
Clinical output reported in the exact-submission ACR model card.
- Limitations
- Exclusion criteria: NA. Supported hardware: Unspecified. Scanner manufacturers: All
Limitations and supported-acquisition details reported in the exact-submission ACR model card.
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.
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.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
- Deployment and data flow
- On-premise
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
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Annalise Enterprise CXR Triage Trauma; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-09Evidence
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
- Study type: Stand-Alone Performance. Cases: 589. Reference standard: Interpretation by Reviewing Clinician. Reported sensitivity: 89.3% (95% CI: 85.7%, 93.0%). Reported specificity: 89.0% (95% CI: 85.8%, 92.1%). Reported accuracy: 95.4% (95% CI: 0.939-0.968). Additional reported metrics: Performance assessed at multiple operating points, refer to Performance Guide
Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.
- Reported sensitivity
- 89.3% (95% CI: 85.7%, 93.0%)
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 89.0% (95% CI: 85.8%, 92.1%)
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 CXR - Vertebral Compression Fracture regulatory performance study summary
- DesignStand-Alone Performance
- PopulationAdult
- Scopeexact submission
- Tested version3.3+
- Samplen=589
- IndependenceIndependence not established
K222268
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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
No public price or quote for the exact K222268 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
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 K222268. 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.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K222268 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Automated sources checkedStatus
2026-09-09Last searched
25Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting review 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. Exact FDA and recall packets were prepared and identity matched, but no new clinical or performance claim was promoted in the conservative fallback. Existing exact-submission facts retain their original source status and applicability; candidate literature remains quarantined. 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, 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
-
FDA K222268: Annalise Enterprise CXR Triage Trauma
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
Annalise CXR - Vertebral Compression Fracture model card (K222268)
Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K222268
Scope: postmarketSafety
Research history
-
K222268 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
automated sources checked
Alternatives
Related tools to compare
FDA-cleared K243808
Rayvolve PTX-PE
AZmed
Passive study-level worklist triage for suspected pneumothorax and/or pleural effusion on adult PA or AP chest X-rays; it is not a proactive specialist alert.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2025-03-21
FDA-cleared K242821
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
Ever Fortune.AI, Co., Ltd.
Passive triage of adult AP chest radiographs for an endotracheal-tube tip more than 7 cm above the carina, less than 3 cm above the carina, below the carina in the right or left...
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2025-02-20
FDA-cleared K241439
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
Vuno Inc.
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence...
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2024-11-15
FDA-cleared K232410
SmartChest
Milvue
Passive worklist prioritization for suspected pleural effusion and/or pneumothorax on frontal PA or AP chest radiographs in transitional adolescents aged 18-21 and adults aged 22...
- Modality
- X-ray/Radiography
- Anatomy
- Chest/lung
- Decision
- 2024-05-10