GE StarGuide system - HSA Registration DE0508086
Access comprehensive regulatory information for GE StarGuide system in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508086 and owned by GE Medical Systems Israel, Functional Imaging. The device was registered on May 12, 2023.
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.
The GE StarGuide system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using tomographic scanning mode supported by various acquisition types, and a Computed Tomography system which is intended for enabling CT-based corrections and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications. Functional-Anatomical Mutual Enhancement (FAME) technology is an image processing method for Nuclear Medicine (NM) bone scintigraphy images. The Lung Cancer Screening Option for Qualified GE CT Systems is indicated for using low-dose CT for lung cancer screening. The screening must be performed within the established inclusion criteria of programs/protocols that have been approved and published by either a governmental body or professional medical society.