GE AMX Navigate X-ray system - HSA Registration DE0508544
Access comprehensive regulatory information for GE AMX Navigate X-ray 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 DE0508544 and owned by GE Medical Systems LLC. The device was registered on October 05, 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 AMX Navigate is intended to take exposures utilizing film, computed radiography (CR), or wireless detectors, which are intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR). The AMX Navigate is indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. The system is indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.