Radiology AI Directory

FDA-cleared profile

Annalise Enterprise CTB Triage-OH

Annalise-AI Pty Ltd

Aid triage and prioritization of adult patients aged 22 years or older with non-contrast brain CT studies containing features suggestive of obstructive hydrocephalus by providing study-level output to an order and imaging management system; the notification is not for standalone clinical decision-making or to rule out the finding.

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.

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
Aid triage and prioritization of adult patients aged 22 years or older with non-contrast brain CT studies containing features suggestive of obstructive hydrocephalus by providing study-level output to an order and imaging management system; the notification is not for standalone clinical decision-making or to rule out the finding.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Trained clinicians who, within their scope of practice, are qualified to interpret brain CT studies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Medical care environment with workflow performed in parallel to standard clinical interpretation; the FDA packet does not specify a facility type.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Post-acquisition case-level triage and notification that prioritizes suspected obstructive-hydrocephalus studies in an image and order management worklist without lowering an existing study priority.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
DICOM-compliant non-contrast brain CT studies from the intended adult population; the FDA performance cohorts included slice-thickness groups of 1.5 mm or less and greater than 1.5 mm through 5.0 mm.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Study-level notification to an image and order management system for suspected obstructive hydrocephalus and worklist prioritization; the device does not direct attention to a specific image portion.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
Limited by the FDA indication to non-contrast brain CT and patients aged 22 years or older. Results are not standalone clinical decisions, do not rule out obstructive hydrocephalus, and do not replace clinical assessment. Performance evidence used independent adult cohorts from five U.S. hospital-network sites and should not be generalized beyond the studied inputs and operating points.
  • 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
K231094
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-08-15
  • 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 states that the device interfaces with image and order management systems such as PACS/RIS to obtain CT studies and return a prioritization notification; exact current interface versions and local compatibility 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-OH; 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
Standalone performance used an independent retrospective anonymized dataset of 175 cases for slice thickness ≤1.5 mm (75 positive, 100 negative) and 191 cases for >1.5 mm to ≤5.0 mm (84 positive, 107 negative) collected from five U.S. hospital-network sites, including community hospitals and academic medical centers. Ground truth used two ABR-certified protocol-trained neuroradiologists with a third in disagreement. FDA sensitivity and specificity were reported separately by slice-thickness range and operating point for obstructive hydrocephalus. A separate internal bench triage-effectiveness study of 277 positive cases reported turnaround of 81.6 seconds (95% CI 80.3-82.9), a latency endpoint distinct from diagnostic performance.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Obstructive-hydrocephalus standalone sensitivity: slice thickness ≤1.5 mm, operating points 0.149943: 97.3% (95% CI 93.3%-100.0%), 0.185900: 94.7% (89.3%-98.7%), and 0.281473: 92.0% (85.3%-97.3%); >1.5 mm and ≤5.0 mm, operating points 0.100591: 97.6% (94.0%-100.0%), 0.149943: 95.2% (90.5%-98.8%), 0.185900: 94.0% (89.3%-98.8%), and 0.281473: 88.1% (81.0%-94.0%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

The FDA endpoint is case-level standalone sensitivity for obstructive hydrocephalus and varies by slice-thickness range and operating point.

Reported specificity
Obstructive-hydrocephalus standalone specificity: slice thickness ≤1.5 mm, operating points 0.149943: 94.0% (95% CI 89.0%-98.0%), 0.185900: 95.0% (90.0%-99.0%), and 0.281473: 97.0% (93.0%-100.0%); >1.5 mm and ≤5.0 mm, operating points 0.100591, 0.149943, 0.185900, and 0.281473: 95.3% (90.7%-99.1%) at each listed operating point.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

The FDA endpoint is case-level standalone specificity for obstructive hydrocephalus and is bounded by the studied slice-thickness ranges and operating points.

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 - obstructive hydrocephalus) regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested version3.3+
  • Samplen=366
  • Sites5
  • IndependenceIndependence not established

K231094

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 K231094 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 K231094. 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
2026-09-09Last 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 scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. 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

  1. FDA K231094: Annalise Enterprise CTB Triage-OH

    U.S. Food and Drug Administration - Published 2023-08-15 - 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 - obstructive hydrocephalus) model card (K231094)

    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 K231094

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

    Scope: postmarketSafety

Research history

  1. K231094 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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