DRGEM FUJIFILM FDR Smart FGXR-ES/ECS Series Diagnostic X-ray System - HSA Registration DE0509092
Access comprehensive regulatory information for DRGEM FUJIFILM FDR Smart FGXR-ES/ECS Series Diagnostic 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 DE0509092 and owned by DRGEM CORPORATION. The device was registered on March 22, 2024.
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.
This diagnostic x-ray system is designed to diagnose human body by providing radiographic x-ray image with anatomical structure. FDR SMART FGXR-ES/ECS System is indicated for use in generating radiographic images of human anatomy. The Diagnostic X-ray System consisting of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, patient table, wall Bucky stand, and a tube, operates on a high-frequency inverter method, and is primarily used in a hospital for diagnosis of diseases in skeletal, respiratory and urinary systems. Such as the skull, spinal column, chest, abdomen, extremities, and other body parts. Not to be used for fluoroscopy, angiography, or screening mammography. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.