Annalise-AI Annalise Enterprise - HSA Registration DE0507316
Access comprehensive regulatory information for Annalise-AI Annalise Enterprise in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507316 and owned by Annalise-AI Pty Ltd. The device was registered on September 29, 2022.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Annalise Enterprise is a medical device intended to assist clinicians with the interpretation of radiological imaging studies and provide notification of suspected findings. Annalise Enterprise identifies suspected findings in digitised (CR) or digital (DX) chest X-ray studies taken in the anterior-posterior (AP) or posterior-anterior (PA) and optionally lateral (LAT) orientations of adult patients The device improves the detection of radiological findings visible on chest X-rays. The device is used on a PC workstation in conjunction with a medical imaging viewer (i.e. PACS system). The device may also be configured to provide input to worklist software to assist with notification and triaging. The device identifies studies with selected findings and communicates these studies to the worklist software which enables triaging of the worklist and notification.