Annalise Container

Primary DI

G140ANNALISECONTAINER50

Basic UDI-DI Code

++G140ANNALISECONTAINERR9

Reference

Annalisecontainer5

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

Annalise-AI Pty Ltd

Annalise Container is an artificial intelligence (AI) driven, software-as-medical-device designed to be compatible in marketplace environment. The device is intended (1) to aid in the clinical assessment of and/ (2) aid in the prioritization and triage of non-contrast Computed Tomography Brain (CTB) cases. The Annalise Container provides case level outputs for the following: • Identification of suspected radiological findings, and • Identification of suspected laterality or highlighting of the relevant areas of interest (Localisation) for a subset of radiological findings. Annalise Container can also be configured to provide input to worklist software to assist with notification and triaging. The device is intended to be used by trained clinicians for the Patients aged 18 years or older who have undergone a non-contrast CT brain scan study who are qualified to interpret CT brain scans as part of their scope of practice.

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDR).