Annalise-AI radiology AI products

FDA-cleared K250831

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...

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Chest/Lung; Brain
Decision: 2025-04-23

Stroke and ICH triage Acute triage and notification

FDA-cleared K213941

Annalise Enterprise CXR Triage Pneumothorax

Annalise-AI

Intended Context Annalise Triage is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of the...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2022-02-24

Stroke and ICH triage Acute triage and notification