Annalise Enterprise CTB
Annalise.ai
Screens non-contrast brain CT for several critical findings simultaneously and issues triage notifications, rather than targeting a single finding class.
At A Glance
- Manufacturer
- Annalise.ai
- Medical specialty
- Radiology
- Clearance route
- 510(k)
- Year authorized
- 2021 onward
- Modality
- CT
- Role in workflow
- Triage and notification
The multi-finding approach is a bet that departments would rather deploy one model covering many findings than integrate several single-purpose ones. Integration cost is real and frequently underestimated, so the argument has weight independent of accuracy.
Where It Is Used
- Intracranial hemorrhage triage
- Mass effect and midline shift flagging
- Multi-finding emergency neuroimaging review
Limitations Worth Knowing
Breadth and depth trade against each other. A model covering many finding classes will be stronger on some than others, and the clearance covers the indications listed in the submission, not every finding the software displays.
Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.