Singapore HSA registration DE0018742
GE Discovery RT
Singapore·CLASS C·GE HangWei Medical Systems Co. Ltd·Registered November 17, 2016Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0018742
- Registration Date
- November 17, 2016
- Change Notification Approval Date
- July 22, 2020
- Retention Due Date
- November 16, 2025
Product description
The GE Discovery RT Computed Tomography Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated (Respiratory and Cardiac) acquisitions. The devices are indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy. The system is capable of assisting with minimally invasive procedures such as biopsy and ablation of tumors and pathology. The system allows imaging of Bariatrics patients, up to and including the morbidly obese population (BMI > 40). The system can acquire CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer.
Product Owner
- Short Name
- GE HangWei Medical Systems Co. Ltd
- Address
- West Area of Building No.3,, No.1 Yongchang North Road., Beijing Economic and Technological, Development Area, 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)
- PDU Gantry GT1700 Table Heavy patient table Discovery RT
- Model Identifier(s)
- 2326492-61 2374681-17 5122080-4 5272966-3 Discovery RT
About this record
Access comprehensive regulatory information for GE Discovery RT in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0018742 and owned by GE HangWei Medical Systems Co. Ltd. The device was registered on November 17, 2016.
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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