Singapore HSA registration DE0504522
GE AW Server 3.2 ext. 3.4 PACS system
Singapore·CLASS C·GE Medical Systems SCS·Registered May 29, 2020Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0504522
- Registration Date
- May 29, 2020
- Retention Due Date
- May 28, 2025
Product description
AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. The device is not intended for diagnosis of mammography images. The device is not intended for diagnosis of lossy compressed images. For other images, trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application. It will be used to create and review diagnostic evidence related to radiology procedures by trained physicals in General Purpose Radiology, Oncology, Cardiology and Neurology Clinical areas.
Product Owner
- Short Name
- GE Medical Systems SCS
- Address
- 283 Rue De La Miniere, 78530 Buc, FRANCE
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)
- SmartScore 4.0 Gemstone Spectral Imaging (GSI) Viewer Advantage 4D Advantage 4D SW and Docs for AW Server Gemstone Spectral Imaging (GSI) Viewer SW and Docs for AW Server AdvantageSim MD SW and Docs for AW Server AdvantageSim MD CT atlas-based contouring and re-planning AdvantageSim MD AdvantageSim MD MR pelvic organ at risk segmentation CortexID Suite CortexID Suite SW & Docs for AW Server CortexID Suite SW & Docs for Virtual AW Server CardIQ Xpress Process SW and Docs for AW Workstation and AW Server CardIQ Xpress Process SW and Docs for Virtual AW Server CardIQ Xpress Process PACS Integration Advantage 4D SW and Docs for Virtual AW Server AdvantageSim MD SW and Docs for Virtual AW Server Gemstone Spectral Imaging (GSI) Viewer SW and Docs for Virtual AW Server AW Server Virtual Node AW Server 3.2 SW and Docs AW Server 3.2 SW and Docs for Virtual Machine AW Server SW Seamless PACS Integration Quantib Brain SW and Docs for AW Workstation and AW Server Quantib Brain Quantib Brain SW and Docs for Virtual AW Server Volume Viewer FlightPlan for Liver Dynamic Shuttle AutoLaunch Integrated Registration CardIQ Xpress Reveal CardIQ Fusion PET CardIQ Fusion SPECT AdvantageCTC Pro3D EC Colon VCAR EC OncoQuant GenIQ MR VesselIQ Xpress VesselIQ Xpress Lung VCAR Thoracic VCAR CardEP AutoBone Xpress CardIQ Function Xpress PET VCAR Volume Viewer Innova CT Perfusion 4D, CT Perfusion 4D Multi-Organ CT Perfusion 4D, CT Perfusion 4D Neuro GSI Volume Viewer GSI MSI FlightPlan for EVAR Stroke VCAR Hepatic VCAR TAVI Analysis FastStroke READY View Body View Brain View MR-Touch PROView Dynamic CT Myocardial Perfusion Q.Freeze 2 cvi42 cvi42 SW and Docs forAW Workstation and AW Server cvi42 SW and Docs for Virtual AW Server GSI Fat DICOM Direct Connect GSI Pulmonary Perfusion Bone VCAR Volume Viewer Apps SW & Docs for AW Workstation and AW Server Volume Viewer Virtual Apps SW and Docs for Virtual AW Server AW Server 3.2 SW and Docs for Virtual Machine CardIQ Flow SmartScore 4.0 SW and Docs for for AW Workstation and AW Server SmartScore SW and Docs for AW Server Volume Illumination CT Perfusion 4D Neuro Gen2 Hepatic VCAR Gen2 PROView Automatic Segment TAVI Analysis Gen2 FlightPlan for Embolization Volume Viewer Apps SW & Docs for AW Server Send by Mail
- Model Identifier(s)
- 5196876-21 5342114-14 5400055-11 5400063-7 5404922-8 5441046-10 5452895-8 5456133-13 5456208-8 5479284-8 5479286-6 5480329-6 5480372-7 5483146-7 5483148-7 5535309-5 5573917-5 5582138-8 5589804-4 5694793-2 5719780-28 5719780-38 5720614-15 5720646-2 5737000-3 5737002-3 5737004-3 5760428-2 5760429-2 5760430-2 5760431-2 5760432-2 5760433-2 5760434-2 5760435-2 5760436-2 5760438-2 5760439-2 5760440-2 5760442-2 5760443-2 5760444-2 5760445-2 5760446-2 5760447-2 5760449-2 5760450-2 5760452-2 5760455-2 5760459-2 5760462 5760466 5760468-2 5760469-2 5760470-2 5760471-2 5760947-2 5760948-2 5761734 5761736 5761737 5774709-2 5774710 5774714 5778788-3 5778797-3 5782165-3 5793385 5797958-3 5810043 5810047-2 5812897-6 5812898-6 5818084-3 5821497-2 5828722 5828723 5835840 5835844 5835845 5835847 5835848 5835850 5837030-2 5837049
About this record
Access comprehensive regulatory information for GE AW Server 3.2 ext. 3.4 PACS 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 DE0504522 and owned by GE Medical Systems SCS. The device was registered on May 29, 2020.
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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