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AW Server 3.2 (Ext.4.0) PACS system - HSA Registration DE0506186

Access comprehensive regulatory information for AW Server 3.2 (Ext.4.0) 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 DE0506186 and owned by GE Medical Systems SCS. The device was registered on September 20, 2021.

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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CLASS C
DE0506186
AW Server 3.2 (Ext.4.0) PACS system
HSA Registration Number: DE0506186
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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.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0506186
Registration Date
September 20, 2021
Retention Due Date
September 19, 2025
Product Owner
Short Name
GE Medical Systems
Address
293, 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 AutoLaunch GSI MSI Body View Brain View MR-Touch Dynamic CT Myocardial Perfusion Q.Freeze 2 cvi42 cvi42 SW and Docs for AW Workstation and AW Server cvi42 SW and Docs for Virtual AW Server GSI Fat DICOM Direct Connect GSI Pulmonary Perfusion AW Server 3.2 SW and Docs for Virtual Machine 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 Segmentation TAVI Analysis Gen2 Send by Mail Volume Viewer Apps SW & Docs for AW Workstation and AW Server Volume Viewer Virtual Apps SW and Docs for Virtual AW Server Volume Viewer Apps SW & Docs for AW Server AutoBone Xpress Bone VCAR CardEP CardIQ Flow CardIQ Function Xpress CardIQ Fusion PET CardIQ Fusion SPECT CardIQ Xpress 2.0 Colon VCAR EC AdvantageCTC Pro3D EC CT Perfusion 4D Multi-Organ CT Perfusion 4D Neuro FastStroke FlightPlan for Embolization FlightPlan for EVAR FlightPlan for Liver GenIQ GSI Viewer Hepatic VCAR Integrated Registration Liver Suite Lung VCAR OncoQuant PET VCAR PROView READY View Stroke VCAR TAVI Analysis Thoracic VCAR MR VesselIQ Xpress VesselIQ Xpress Volume Viewer Dynamic Shuttle Volume Viewer Innova Volume Viewer Apps PET VCAR DEAUVILLE GSI Materials GSI Gout CardIQ Xpress 2.0 Reveal DLย  Parenchymal Analysis READY View AD/RD
Model Identifier(s)
5196876-22 5342114-14 5400055-12 5400063-7 5404922-8 5441046-11 5452895-8 5456133-15 5456208-8 5479284-8 5479286-6 5480329-6 5480372-7 5483146-7 5483148-7 5535309-5 5573917-5 5582138-9 5589804-4 5694793-3 5719780-29 5719780-39 5720614-17 5720646-3 5737000-4 5737002-4 5737004-4 5760431-3 5760466 5761734 5761736 5761737 5774710 5774714 5778788-5 5778797-5 5782165-5 5793385 5797958-3 5810043 5818084-4 5828722 5828723 5835840 5835844 5835845 5835847 5835848 5837049 5842656 5842657 5842658 5854342 5854343 5854344 5854345 5854346 5854347 5854348 5854349 5854350 5854351 5854352 5854353 5854354 5854355 5854356 5854357 5854358 5854359 5854360 5854361 5854362 5854363 5854364 5854365 5854366 5854368 5854369 5854370 5854371 5854372 5854373 5854374 5854375 5854376 5862599 5865058 5865060 5865061 5865062 5865063 5865064