Singapore HSA registration DE0503625
GE Discovery XR656 HD Digital Radiographic System
Singapore·CLASS C·GE Hualun Medical Systems Co Ltd·Registered September 23, 2019Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0503625
- Registration Date
- September 23, 2019
- Change Notification Approval Date
- January 05, 2021
- Retention Due Date
- September 22, 2025
Product description
Discovery XR656 HD 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 the system is intended for use in all routine radiography exams. Optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. With AutoGrid option, AutoGrid can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation. With VolumeRAD option, the system can generate tomographic images of human anatomy including the skull, spinal column, chest, abdomen, extremities, etc. in patients of all ages. VolumeRAD is also indicated for detection of lung nodules for patients undergoing thoracic imaging. Device is not intended for mammographic or dental applications
Product Owner
- Short Name
- GE Hualun Medical Systems Co Ltd
- Address
- No.1 Yong Chang North Road, Beijing Economic Technological, Development Zone, Beijing, 100176, CHINA
Registrant
- Address
- 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
- Address
- 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
- Model Name(s)
- Overhead Tube Suspension Overhead Tube Suspension FlashPad HD 2530 FlashPad HD 3543 FlashPad HD 4343 Discovery XR656 HD System Cabinet Wallstand Radiographic Table Wallstand
- Model Identifier(s)
- 5135678-7 5135678-8 5771012 5771417 5771717 Discovery XR656 HD GCC-C3 GCEWS-C3 GCTBL-C3 GCWS-C3
About this record
Access comprehensive regulatory information for GE Discovery XR656 HD 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 DE0503625 and owned by GE Hualun Medical Systems Co Ltd. The device was registered on September 23, 2019.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C