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AW Server 3.2 (Ext.4.9) PACS system - HSA Registration DE0508335

Access comprehensive regulatory information for AW Server 3.2 (Ext.4.9) 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 DE0508335 and owned by GE Medical Systems SCS. The device was registered on July 27, 2023.

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
DE0508335
AW Server 3.2 (Ext.4.9) PACS system
HSA Registration Number: DE0508335
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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
DE0508335
Registration Date
July 27, 2023
Retention Due Date
July 26, 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 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 3.2 Quantib Brain SW and Docs for AW Workstation and AW Server Quantib Brain Quantib Brain SW and Docs for Virtual AW Server cvi42 cvi42 SW and Docs for AW Workstation and AW Server cvi42 SW and Docs for Virtual AW Server SmartScore 4.0 SW and Docs for for AW Workstation and 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 EVAR FlightPlan for Liver GenIQ GSI Viewer Hepatic VCAR Integrated Registration Lung VCAR OncoQuant PET VCAR PROView Stroke VCAR TAVI Analysis Thoracic VCAR MR VesselIQ Xpress VesselIQ Xpress Volume Viewer Dynamic Shuttle Volume Viewer Innova CardIQ Suite READY View Liver Suite SmartScore SW and Docs for AW Server FlightPlan for Embolization
Model Identifier(s)
5196876-23 5342114-14 5400055-13 5400063-8 5404922-8 5441046-11 5452895-8 5456133-15 5456208-8 5479284-9 5479286-7 5480329-7 5480372-7 5483146-7 5483148-7 5573917-6 5582138-9 5589804-4 5719780 5737000-4 5737002-4 5737004-4 5778788-7 5778797-7 5782165-7 5828722-2 5854342 5854343 5854344 5854345 5854346 5854347 5854348 5854349 5854350 5854351 5854352 5854353 5854354 5854356 5854357 5854358 5854359 5854360 5854361 5854363 5854364 5854365 5854366 5854369 5854370 5854371 5854372 5854373 5854374 5854375 5854376 5882923 5890197 5918502 5926357 5927105