GE Critical Care Suite - HSA Registration DE0505081
Access comprehensive regulatory information for GE Critical Care Suite in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505081 and owned by GE Medical Systems LLC. The device was registered on October 27, 2020.
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 computer aided triage and notification device that analyzes frontal chest xray images for the presence of prespecified critical findings (pneumothorax). Critical Care Suite identifies images with critical findings to enable case prioritization in the PACS/workstation. Critical Care Suite is intended for notification only and does not provide diagnostic information beyond the notification. Critical Care Suite should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. It is not intended to replace the review of the xray image by a qualified physician. Critical Care Suite is indicated for adult-size patients.