GE Optima XR646 Digital Radiographic System - HSA Registration DE0017376
Access comprehensive regulatory information for GE Optima XR646 Digital Radiographic 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 DE0017376 and owned by GE Hualun Medical Systems Co Ltd. The device was registered on July 30, 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.
The Optima XR646 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts in patients of all ages. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position and is intended for use in all routine radiography exams. The device is not intended for mammographic applications.