GE Revolution EVO CT system - HSA Registration DE0017413
Access comprehensive regulatory information for GE Revolution EVO CT 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 DE0017413 and owned by GE Healthcare Japan Corporation. The device was registered on August 14, 2015.
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.
System is intended to produce cross-sectional body images by computer reconstruction of x-ray transmission data at different angles & planes, including Axial, Cine, Helical (Volumetric), Cardiac & Gated acquisitions, with or without contrast. Device may include signal analysis & display equipment, patient & equipment supports, components & accessories, data & image processing to produce images in trans-axial & reformatted planes. Images can be post processed to produce additional imaging planes/analysis results. System is indicated for head, whole body, cardiac & vascular X-ray CT applications in patients of all ages. Device output is used for diagnosis of disease,trauma,or abnormality & for planning, guiding & monitoring therapy. System is indicated for using low-dose CT for lung cancer screening. Screening must be performed within the established inclusion criteria of programs/protocols that have been approved & published by either a governmental body or professional medical society.