Annalise Enterprise prioritizes and notifies trained CT clinicians of suspected acute infarct on non-contrast brain CT for adults; it is a study-level, non-localizing worklist aid and never downgrades an existing priority.
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
Annalise Enterprise prioritizes and notifies trained CT clinicians of suspected acute infarct on non-contrast brain CT for adults; it is a study-level, non-localizing worklist aid and never downgrades an existing priority.
FDA source Exact FDA submission Checked 2026-09-05
The device is not a rule-out tool, does not replace advanced stroke imaging or standard care, and excludes lacunar, brainstem, and venous infarcts from its acute-infarct definition.
FDA source Exact FDA submission Checked 2026-09-05
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
K253818
FDA source Exact FDA submission Checked 2026-08-31
Vendor confirmation Exact FDA submission Checked 2026-09-05
Current hosting model was not established in the reviewed material.
Security and privacy
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-06
No dated, scoped security documentation was reviewed.
Training and support
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-06
Current training/support commitments were not established.
Monitoring and change control
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-08-13
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Current vendor family context
Harrison.ai describes a broader CT-brain suite and an acute-infarct triage clearance announcement.
product family · checked 2026-09-05
Broader suite finding counts and workflows are not assumed for this exact acute-infarct configuration.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
A retrospective study used consecutive cases from five U.S. hospital networks, with separate thin- and thick-slice cohorts and expert reference standards.
FDA source Exact FDA submission Checked 2026-09-05
Annalise Enterprise acute-infarct regulatory performance study
Retrospective multicenter standalone performance study · Consecutive cases from five U.S. hospital networks; 977 thin-slice and 1,050 thick-slice CT cases
exact submission · Tested version: Annalise Enterprise submitted in K253818; build not stated · n=2027 · 5 sites · Independence not established
K253818
Reference standard used two expert readers with third-reader adjudication; advanced imaging was available. Metrics above are thin-slice only.
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 2026-09-06
No scoped public price or procurement award was reviewed.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-09-06
No applicable payer policy was reviewed; vendor-wide reimbursement claims were not treated as policy evidence for this function.
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
Reviewed sources checked Exact FDA submission Checked 2026-09-04
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
Verify deployment and data flow: Current hosting model was not established in the reviewed material.
Verify security and privacy controls: No dated, scoped security documentation was reviewed.
Verify training: Current training/support commitments were not established.
Verify pricing and total cost: No scoped public price or procurement award was reviewed.
Verify reimbursement and coding relevance: No applicable payer policy was reviewed; vendor-wide reimbursement claims were not treated as policy evidence for this function.
Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-05Last searched
25Fields reviewed
10Source classes checked
0Reviewed PubMed leads
0Reviewed trial leads
0Unreviewed FDA recall leads
No stored PubMed or ClinicalTrials candidates. Native-submission recall candidate snapshot was zero. 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, acr ai central product, fda decision material, vendor product page, literature index, trial registry, fda device recall, pubmed, clinical trials, openfda device recall
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...
FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...