Notification and worklist prioritization
The cleared product returns study-level notifications for listed findings rather than image markup or a standalone clinical decision.
exact submission · checked 2026-09-07FDA-cleared profile
Annalise Enterprise
Annalise-AI
Triage and prioritization of adult CXR and non-contrast brain CT studies for specified suspected findings, including pneumoperitoneum, pleural effusion, pneumothorax and tension pneumothorax on CXR, and acute extra-axial hemorrhage, subarachnoid hemorrhage, intra-axial hemorrhage, intraventricular hemorrhage, mass effect, obstructive hydrocephalus and vasogenic edema on brain 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
- Triage and prioritization of adult CXR and non-contrast brain CT studies for specified suspected findings, including pneumoperitoneum, pleural effusion, pneumothorax and tension pneumothorax on CXR, and acute extra-axial hemorrhage, subarachnoid hemorrhage, intra-axial hemorrhage, intraventricular hemorrhage, mass effect, obstructive hydrocephalus and vasogenic edema on brain CT.
- Intended users
- Radiologists and other qualified healthcare professionals interpreting adult chest radiographs and non-contrast brain CT.
- Care setting and population
- Adult hospital and outpatient imaging workflows using chest radiography and non-contrast brain CT.
- Workflow role
- Notification-only study triage and prioritization; the product is not a standalone clinical decision tool or a rule-out system.
- Required input
- CXR: at least one frontal AP or PA view, with up to three images total and lateral views supported. CTB: non-contrast axial brain CT, up to 1,000 images, slice thickness <=5 mm, using a brain reconstruction kernel or similar.
- Output and human action
- Study-level abnormality notifications and prioritization information for the listed CXR and brain-CT findings; final interpretation remains with the clinician.
- Limitations
- Cleared adult use is limited to the listed findings and input requirements. Notifications do not replace image interpretation, are not a standalone clinical decision, and should not be treated as a negative rule-out result.
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
- K250831
- Modality
- Radiological images; modality varies or is not specified in FDA list
The submission is multi-modality. The input fact preserves the exact CXR and CT requirements rather than collapsing the product to one modality.
- Anatomy
- Chest/Lung; Brain
- Clearance type
- 510(k)
- Decision date
- 2025-04-23
- 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
- The submission describes study-level integration with the radiology worklist/PACS workflow for notification and prioritization; exact local routing and reader configuration require site confirmation.
- Deployment and data flow
- Annalise Enterprise is described in the FDA submission as software integrated into the imaging workflow; the exact site hosting model for this submission is not established in the public summary.
- Security and privacy
- The family administration guide describes protected data transfer and configurable retention/deletion behavior for Annalise Enterprise.
This is family context only, not an exact-release certification, penetration-test result or site-specific security assessment for K250831.
- Training and support
- Vendor documentation pending
The reviewed guides describe administration but do not establish site-specific training deliverables for K250831.
- Monitoring and change control
- Vendor documentation pending
No exact-release clinical performance monitoring or drift program was established.
PACS/RIS workflow administration
The official Comprehensive Care page describes PACS/RIS workflow integration, and the Annalise administration documentation describes configurable PACS/RIS interfaces for the family.
product family · checked 2026-09-07Connector availability, hosting and configuration for K250831 require vendor/site confirmation; the administration PDF was reviewed via web-rendered/cached fulltext after a direct-fetch 403.
Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- Evidence summary
- The reviewed FDA summary establishes the multi-modality intended-use and input boundaries for Annalise Enterprise 3.10+ but does not provide a single consolidated performance metric suitable for this dossier.
- Reported sensitivity
- Op 0.250: 96.2% (92.4,99.0), Op 0.300: 94.3% (89.5,98.1) , Op 0.350: 92.4% (86.7,97.1) , Op 0.400: 91.4% (85.7,96.2), Op 0.450: 87.6% (81.0,93.3)
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- Op 0.225: 87.9% (83.2,92.1), Op 0.250: 90.5% (86.3,94.2), Op 0.300: 93.7% (90.0,96.8), Op 0.350: 95.8% (92.6,98.4), Op 0.400: 98.4% (96.3,100.0)
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 Enterprise 3.10+ multi-modality validation
Regulatory software and performance evidence described in the FDA 510(k) summary · Adult chest radiographs and non-contrast brain CT studies within the listed input requirements
exact submission · Tested version: Annalise Enterprise 3.10+ · Sponsor or vendor studyK250831
The reviewed public summary was used for indication, input and workflow boundaries; no consolidated disease-performance value is promoted here.
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
No public price or quote for K250831 was reviewed.
- Reimbursement and coding
- Research pending
Payer policy research was not part of this worker's scope.
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
The downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
Buyer worksheet
Open questions to take to the vendor
- Verify training: The reviewed guides describe administration but do not establish site-specific training deliverables for K250831.
- Verify pricing and total cost: No public price or quote for K250831 was reviewed.
- Verify reimbursement and coding relevance: Payer policy research was not part of this worker's scope.
- Verify local validation and lifecycle monitoring: No exact-release clinical performance monitoring or drift program was established.
- Verify recalls and postmarket safety signals: The downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-07Last searched
23Fields reviewed
11Source classes checked
0Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
Stored candidate metadata was screened; no PubMed or trial IDs were returned for this submission. This is not a full-paper review. 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, vendor product page, vendor technical documentation, stored candidate metadata, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources
Source ledger
Sources accessed through 2026-09-07.
- FDA 510(k) K250831: Annalise Enterprise U.S. Food and Drug Administration · 2026-09-07
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- Harrison.ai Comprehensive Care (CXR - pneumoperitoneum) model card (K250831) 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
- Harrison.ai Comprehensive Care: chest X-ray and non-contrast head CT Harrison.ai / Annalise.ai · 2026-09-07
- Annalise Enterprise Administration Guide 8 Annalise.ai · 2026-09-06
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