Annalise Enterprise

Primary DI

G140ANNALISEENTP30

Basic UDI-DI Code

++G140AnnaliseEnterprisEM

Reference

AnnaliseENTP3

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

Annalise-AI Pty Ltd

Annalise Enterprise is a clinical decision support application which uses artificial intelligence (AI) algorithms to assist clinicians with the interpretation of radiological imaging studies. It is compatible with image and order management systems such as picture archiving and communication systems (PACS) and radiological information systems (RIS). The suspected findings are communicated to the clinician viewing the study by displaying the findings and associated localisation information to the clinician as they view the study in the PACS viewer. Additionally, the device may be configured to provide input to worklist software to assist with notification and triaging. The device identifies studies with selected findings (as defined by the customer) and communicates these studies to the worklist software which enables triaging of the worklist and notification. The output of Annalise Enterprise may be used in other products and/or modules to provide information to the intended users as specified in the Annalise Enterprise findings list. Annalise Enterprise contains the following: • Annalise Viewer • Annalise Secondary Capture • Worklist Triage

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).