GE Critical Care Suite 2.0 - HSA Registration DE0508921
Access comprehensive regulatory information for GE Critical Care Suite 2.0 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508921 and owned by GE Medical Systems LLC. The device was registered on February 05, 2024.
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.
Critical Care Suite is a suite of AI algorithms for the automated image analysis of frontal chest X-rays acquired on a digital x-ray system for the presence of critical findings, quality checks and/or measurements. When Critical Care Suite includes the Pneumothorax algorithm, it produces an onscreen notification, image overlay, and an image flag to enable case prioritization and diagnosis of critical findings (pneumothorax). This information is also transmitted to the radiologist for review When Critical Care Suite includes the Endotracheal Tube algorithm, it produces an on-screen image overlay that detects and localizes an endotracheal tube, locates the endotracheal tube tip, locates the carina, and automatically calculates the vertical distance between the endotracheal tube tip and carina. This information is also transmitted to the radiologist for review.