Singapore HSA registration DE0017414
GE Optima CT520 CT Scanner System
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90221400
Registration information
- Registration Number
- DE0017414
- Registration Date
- August 14, 2015
- Change Notification Approval Date
- May 21, 2019
- Retention Due Date
- August 13, 2025
Product description
The GE Optima CT520 Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, patient for all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results. The GE Optima CT520 CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
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)
- Standard cover kit CONNECTPRO HIS-RIS SW KEY LINUX HOSPITAL INFO SYS RADIOLOGY SYS INFO AVA Xpress Advantage CTC Pro3D EC AutoBone Xpress CT Perfusion 4D Neru CT Perfusion 4D Multi-Organ DentaScan Gantry Accessory I/F Kit Optima CT520 Recon enhancement Package Overlapped Reconstruction Standard cover kit Organ Dose Modulation Ultra Kernel Xtream Injector Enhanced Xtream Injector Smart Score Pro Acquisition Software ECG Trace on OC Software Exam Split Volume Viewer
- Model Identifier(s)
- B70762RT B7500LN B75022AE B75032AE B75042AE B75062AE B75072AE B7540LS B75492CB B76922CB B77002CB B77012CB B77092CB B77102CB B77112CB B77372CA B77382CA B7850PL B7864KC B7864KH B7870JA
About this record
Access comprehensive regulatory information for GE Optima CT520 CT Scanner 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 DE0017414 and owned by GE HangWei Medical Systems Co. Ltd. The device was registered on August 14, 2015.
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