GE Optima CT580 - HSA Registration DE0015213
Access comprehensive regulatory information for GE Optima CT580 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0015213 and owned by GE HangWei Medical Systems Co. Ltd. The device was registered on April 21, 2014.
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.
Optima CT580 CT Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles & planes, including Axial, Cine, Helical (Volumetric), & Gated (Respiratory & Cardiac) acquisitions. The devices are indicated for head, whole body, & vascular X-ray Computed Tomography applications in patients of all ages. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality & for planning, guiding, & monitoring therapy. The system is capable of assisting with minimally invasive procedures such as biopsy & ablation of tumors & pathology. The system allows imaging of Bariatrics patients, up to & including the morbidly obese population (BMI > 40). The system can acquire CT anatomical images that are clinically useful in the simulation & planning of radiation therapy for the treatment of cancer