FDA-cleared profile

Annalise Enterprise CXR Triage Trauma

Annalise-AI Pty Ltd

Authorized purpose: Triage and prioritization of adult chest X-ray cases suggestive of pleural effusion or pneumoperitoneum.

Acute 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 chest X-ray cases suggestive of pleural effusion or pneumoperitoneum.

Overview status: Source-reviewed overview

What does this software do? Authorized purpose: Triage and prioritization of adult chest X-ray cases suggestive of pleural effusion or pneumoperitoneum.
Which images or clinical context are in scope? Modality: X-ray/Radiography Anatomy or clinical context: Chest Input: Adult DICOM-compliant chest X-ray studies obtained through image and order management systems; evaluation included supine and erect positioning.
Who uses it? Intended users: Trained clinicians qualified to interpret chest X-rays.
What does the software produce? Output: Case-level notification to PACS or RIS for worklist prioritization or triage; existing study priority is not lowered and no image location is marked.
What is its most important limitation? Key limitation: Not standalone and not a rule-out device; only pleural effusion and pneumoperitoneum are identified; prone positioning, unilateral left-sided pneumoperitoneum, scarring, and pleural thickening may affect performance.

Clinical takeaway

Clinical role: Triage and prioritization of adult chest X-ray cases suggestive of pleural effusion or pneumoperitoneum.

Evidence takeaway

Evidence from the reviewed source record: FDA packet reports two retrospective cohorts totaling 1,269 adult DICOM CXR cases, 582 positive and 687 negative, from four US hospital-network sites; AUC was 0.980 for pleural effusion and 0.969 for pneumoperitoneum.

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 chest X-ray cases suggestive of pleural effusion or pneumoperitoneum.

Intended users: Trained clinicians qualified to interpret chest X-rays.

Care setting and population: Adult

Workflow role: Triage or notification support

Required input: Adult DICOM-compliant chest X-ray studies obtained through image and order management systems; evaluation included supine and erect positioning.

Output and human action: Case-level notification to PACS or RIS for worklist prioritization or triage; existing study priority is not lowered and no image location is marked.

Limitations: Not standalone and not a rule-out device; only pleural effusion and pneumoperitoneum are identified; prone positioning, unilateral left-sided pneumoperitoneum, scarring, and pleural thickening may affect performance.

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: K222179

Modality: X-ray/Radiography

Anatomy: Chest

Clearance type: 510(k)

Decision date: 2023-03-28

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

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 2026-09-09

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 two retrospective cohorts totaling 1,269 adult DICOM CXR cases, 582 positive and 687 negative, from four US hospital-network sites; AUC was 0.980 for pleural effusion and 0.969 for pneumoperitoneum.

Reported sensitivity: Pneumoperitoneum: 82.2% (95% CI: 75.2%, 89.1%) Pleural Effusion: 93.8% (95% CI: 91.5%, 95.8%)

Reported specificity: Pneumoperitoneum: 96.2% (95% CI: 93.4%, 98.9%) Pleural Effusion: 91.7% (95% CI: 89.3%, 94.1%)

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

Annalise CXR - Pneumoperitoneum / Pleural Effusion regulatory performance study summary

DesignStand-Alone Performance
PopulationAdult
Scopeexact submission
Tested version3.3+
IndependenceIndependence not established

K222179

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

Reimbursement and coding: Not established in reviewed sources

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 K222179. 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 K222179 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.

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

FDA K222179: Annalise Enterprise CXR Triage Trauma

U.S. Food and Drug Administration - Published 2023-03-28 - Accessed 2026-09-19

Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary
Artificial Intelligence-Enabled Medical Devices

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

Scope: regulatoryIdentity, modalityContext
Annalise CXR - Pneumoperitoneum / Pleural Effusion model card (K222179)

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

Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, anatomy, evidenceStudies, implementationCapabilities
PubMed biomedical literature index

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

Scope: evidenceDiscovery
ClinicalTrials.gov study registry

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

Scope: evidenceDiscovery, studyStatus
openFDA Device Recall API

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

Scope: recallDiscovery, nativeSubmissionMatching
openFDA exact recall query for K222179

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

Scope: postmarketSafety

Research history

2023-03-28

K222179 FDA decision

Regulatory record

510(k)
2026-09-20

Source-review record updated

Research record

fda record reviewed
2026-09-20

Reader overview source-reviewed

Editorial review

Source-reviewed editorial overlay

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