Radiology AI Directory

FDA-cleared profile

Annalise Enterprise CTB Triage Trauma

Annalise-AI Pty Ltd.

Authorized purpose: Study-level triage and prioritization notification for suspected mass effect on non-contrast brain CT in patients aged 22 years and older; not a stand-alone decision or rule-out tool.

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: Study-level triage and prioritization notification for suspected mass effect on non-contrast brain CT in patients aged 22 years and older; not a stand-alone decision or rule-out tool.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Study-level triage and prioritization notification for suspected mass effect on non-contrast brain CT in patients aged 22 years and older; not a stand-alone decision or rule-out tool.

Evidence takeaway

Evidence from the reviewed source record: FDA packet: standalone evaluation used independent cohorts of 626 cases at slice thickness at most 1.5 mm (493 positive, 133 negative) and 762 cases above 1.5 mm through 5.0 mm (594 positive, 168 negative), collected from 5 U.S. hospital-network sites. Two ABR-certified, protocol-trained neuroradiologists established consensus with a third for disagreement. Mass-effect sensitivity/specificity were, respectively, 97.0%/88.7% and 96.6%/89.5% at the two <=1.5 mm operating points, and 96.8%/89.3% and 95.3%/92.9% at the two >1.5 mm to <=5.0 mm operating points. A separate n=277 positive-case triage bench study reported turnaround time 81.6 seconds (95% CI 80.3-82.9).

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
Study-level triage and prioritization notification for suspected mass effect on non-contrast brain CT in patients aged 22 years and older; not a stand-alone decision or rule-out tool.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Trained clinicians qualified within their scope of practice to interpret brain CT studies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Medical care environment using an order and imaging management/worklist system for adult brain CT.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Parallel case-level mass-effect notification and worklist prioritization without directing attention to a specific image region.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
DICOM-compliant non-contrast brain CT studies from patients aged 22 years or older.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
A study-level notification of suspected mass effect delivered to the order and imaging management system for worklist prioritization or triage; no image-region marking or directed attention is provided.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
Results are not for stand-alone clinical decision-making, ruling out a finding, or precluding clinical assessment of CTB studies; the device only identifies mass effect and the clinician remains responsible for interpreting the full study.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

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
K231384
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Brain/head
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-09-22
  • 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
The FDA packet describes interfaces with image and order management systems such as PACS/RIS for non-contrast brain CT input and worklist notification output; the device does not lower a study's existing worklist priority, and exact local interfaces/versions are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
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

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: standalone evaluation used independent cohorts of 626 cases at slice thickness at most 1.5 mm (493 positive, 133 negative) and 762 cases above 1.5 mm through 5.0 mm (594 positive, 168 negative), collected from 5 U.S. hospital-network sites. Two ABR-certified, protocol-trained neuroradiologists established consensus with a third for disagreement. Mass-effect sensitivity/specificity were, respectively, 97.0%/88.7% and 96.6%/89.5% at the two <=1.5 mm operating points, and 96.8%/89.3% and 95.3%/92.9% at the two >1.5 mm to <=5.0 mm operating points. A separate n=277 positive-case triage bench study reported turnaround time 81.6 seconds (95% CI 80.3-82.9).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Standalone Mass Effect endpoints: slice thickness <=1.5 mm, operating point 0.160195 = 97.0% (95% CI 95.3%-98.4%) and operating point 0.221484 = 96.6% (94.9%-98.2%); slice thickness >1.5 mm and <=5.0 mm, operating point 0.120944 = 96.8% (95.3%-98.1%) and operating point 0.160195 = 95.3% (93.6%-97.0%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

These are separate slice-thickness and operating-point mass-effect sensitivity endpoints; triage turnaround time is not accuracy.

Reported specificity
Standalone Mass Effect endpoints: slice thickness <=1.5 mm, operating point 0.160195 = 88.7% (95% CI 83.5%-94.0%) and operating point 0.221484 = 89.5% (84.2%-94.0%); slice thickness >1.5 mm and <=5.0 mm, operating point 0.120944 = 89.3% (84.5%-93.5%) and operating point 0.160195 = 92.9% (88.7%-96.4%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

These are separate slice-thickness and operating-point mass-effect specificity endpoints; do not collapse them into one unqualified value.

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

Harrison.ai Comprehensive Care (CTB - mass effect) regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested version3.3+
  • Samplen=1388
  • IndependenceIndependence not established

K231384

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 K231384 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 K231384. 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
26Fields reviewed
9Source 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, 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 K231384: Annalise Enterprise CTB Triage Trauma

    U.S. Food and Drug Administration - Published 2023-09-22 - Accessed 2026-09-09

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Harrison.ai Comprehensive Care (CTB - mass effect) model card (K231384)

    American College of Radiology - Published 2026-08-17 - 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 K231384

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

    Scope: postmarketSafety

Research history

  1. K231384 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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