Singapore HSA registration DE0015214
GE Discovery CT590 RT
Singapore·CLASS C·GE Hangwei Medical Systems, Co. Ltd·Registered April 21, 2014Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90221200
Registration information
- Registration Number
- DE0015214
- Registration Date
- April 21, 2014
- Retention Due Date
- April 20, 2026
Product description
Discovery CT590 RT CT Systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles & planes, including Axial, Cine, Helical (Volumetric), & Gated (Respiratory & Cardiac) acquisitions. The devices are indicated for head, whole body, & 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 & for planning, guiding, & monitoring therapy. The system is capable of assisting with minimally invasive procedures such as biopsy & ablation of tumors & pathology. The system allows imaging of Bariatrics patients, up to & including the morbidly obese population (BMI > 40). The system can acquire CT anatomical images that are clinically useful in the simulation & planning of radiation therapy for the treatment of cancer
Product Owner
- Short Name
- GE Hangwei Medical Systems, Co. Ltd
- Address
- No.2 North Yong Chang Street Beijin, Economic & Tech Development Zone, Beijing, 100176, China, 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 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model information
- Model Name(s)
- Dolly Collector Phantom Kit Xray tube assembly Generator (tank) Cables Generator (inverter) Dolly Collector Generator (auxiliary box) SmartView Fluoro Pkg - no monitor SmartStep DentaScan on OC SmartScore Volume Viewer on OC Advanced Vessel Analysis Xpress on OC ConnectPro SW Only Adv 4D with IPC board, Advantage 4D Gantry Varian RPM hardware set AutoBone Xpress on OC SmartStep w/Boom (new Boom) Boom Upgrade Cable Kit for IB Exam Split FX Noise Reduction Filter EKG Viewer Advantage CTC Pro for OC Collimator SMARTSTEP KIT SmartView Fluoro Pkg - with monitor Xtream Injector, Enhanced Xtream Injector Diacor Carbon Overlay VCT 0.625mm Thickness Option SmartScore 4.0 Neuro 3D Filter Adv 4D with IPC board, Cable-Gantry to rpm unit IVY 3150B ECG SmartScorePro Xtream Injector Enhanced Xtream Injector Gantry Accessory I/F HW option Adv 4D with IPC board, RT V3 gantry IPC ASSEM Adaptor - SMRT Step GOC Perf 4 - Multi - Organ on the OC Perf 4 - Neuro on the OC Nemoto Injector Respiratory Triggering Option SW Neuro 3D Filter CT Cover Starter Kit Tube License Option Anzai hardware set GPU Fluoro prerequisite ASIR NIO16 Collector & Upgrade Kit (NIO16) Enhanced Recon Patient 16 Slice Adv 4D on Console Discovery CT590 RT Package Standard NIO16 Collector Smart - speed option Global Scan Control Board ASIR Upgrade Kit (NIO16) Operator Console Ship Collector Option Key - Included in Tech Pub Option Key - Included in Tech Pub Anzai hardware set Tech Pub/OS/Std SW Options Deviceless 4D IB package MAR sw for VCP IB MAR sw for VCP IB MAR sw for VCP IB RTP COUCH GT1700/2000/PET
- Model Identifier(s)
- 2128417-x 2180544-x 2219500-x 2266521-x 2281840-x 2281950-x 2282714-x 2324118-x 2345629-100 2360526-x 2360557-x 2360572-x 2360580-x 2360622-x 2371407-x 2373314-x 2374681-x 2398453-x 5114094-x 5115174-x 5115182-x 5133030-x 5133036-x 5133038-x 5133080-x 5140001-x 5149705-x 5154451-x 5169456-x 5171553-x 5178571-x 5196876-x 5199402-x 5199717-x 5304770-x 5317312-x 5318225-x 5318561-x 5321858-1EN 5323070-x 5323350-x 5327095-x 5327096-x 5328194-x 5328275-x 5329777-x 5330672-x 5335612-x 5337892-x 5340983 5340995-x 5344374-x 5351389-x 5351522-x 5357723-x 5364581 5368097-x 5368687-x 5411192-x 5411378-x 5422825-x 5423054-2 5426363-x 5432300-x 5461986-x 5479517-x 5479689-x 5486358-x 5492362-x E8505MJ
About this record
Access comprehensive regulatory information for GE Discovery CT590 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 DE0015214 and owned by GE Hangwei Medical Systems, Co. Ltd. The device was registered on April 21, 2014.
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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