Singapore HSA registration DE0509092
DRGEM FUJIFILM FDR Smart FGXR-ES/ECS Series Diagnostic X-ray System
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0509092
- Registration Date
- March 22, 2024
- Retention Due Date
- March 21, 2026
Product description
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.
Product Owner
- Short Name
- DRGEM CORPORATION
- Address
- 7F E-B/D Gwangmyeong Techno-Park 60, Haan-ro, Gwangmyeong-si, Gyeonggi-do, 14322, KOREA, REPUBLIC OF
Registrant
- Address
- 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Importer
- Address
- 10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Model information
- Model Name(s)
- FUJIFILM COLLIMATOR FUJIFILM DIAGNOSTIC X-RAY SYSTEM FUJIFILM DIAGNOSTIC X-RAY SYSTEM FUJIFILM DIAGNOSTIC X-RAY SYSTEM FUJIFILM DIAGNOSTIC X-RAY SYSTEM FUJIFILM DIAGNOSTIC X-RAY SYSTEM FUJIFILM DIAGNOSTIC X-RAY SYSTEM FUJIFILM DIAGNOSTIC X-RAY SYSTEM FUJIFILM DIAGNOSTIC X-RAY SYSTEM FUJIFILM DIAGNOSTIC X-RAY SYSTEM FUJIFILM TABLE FUJIFILM TUBE STAND FUJIFILM TUBE STAND FUJIFILM BUCKY STAND FUJIFILM BUCKY STAND
- Model Identifier(s)
- DXC-RML FDR Smart FGXR-EC20S FDR Smart FGXR-EC25S FDR Smart FGXR-EC32S FDR Smart FGXR-EC40S FDR Smart FGXR-EC50S FDR Smart FGXR_E20S FDR Smart FGXR_E25S FDR Smart FGXR_E32S FDR Smart FGXR_E40S PBT-E TS-FT4 TS-FT6 WBS WBS-E
About this record
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.
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