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AW Server 3.2 - HSA Registration DE0510658

Access comprehensive regulatory information for AW Server 3.2 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510658 and owned by GE Medical Systems SCS. The device was registered on May 01, 2025.

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
DE0510658
AW Server 3.2
HSA Registration Number: DE0510658
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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
DE0510658
Registration Date
May 01, 2025
Retention Due Date
April 30, 2026
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 Advantage 4D Advantage 4D SW and Docs for AW Server 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 AW Server 3.2 Quantib Brain SW and Docs for AW Workstation and AW Server Quantib Brain SmartScore SW and Docs for for AW Workstation and AW Server SmartScore SW and Docs for AW Server BreView SnapShot Freeze 2 CardIQ Suite VersaViewer 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 FastStroke FlightPlan for Embolization FlightPlan for EVAR FlightPlan for Liver GenIQ GSI Viewer Hepatic VCAR Integrated Registration Liver Suite Lung VCAR OncoQuant PET VCAR MR VesselIQ Xpress PROView READY View Stroke VCAR TAVI Analysis Thoracic VCAR VesselIQ Xpress Volume Viewer Dynamic Shuttle Volume Viewer Innova DynamicIQ AdvantageSim MD 9.0 cvi42 cvi42 SW and Docs for AW Workstation and AW Server
Model Identifier(s)
5196876-23 5400055-13 5400063-8 5479284-9 5479286-7 5480329-7 5480372-7 5483146-7 5483148-7 5573917-6 5719780 5737000-5 5737002-5 5828722-2 5926357 5942367 5963072 5964975 5964976 5970967 5970968 5970969 5970970 5970971 5970972 5970973 5970974 5970975 5970976 5970977 5970978 5970979 5970980 5970981 5970982 5970983 5970984 5970985 5970986 5970987 5970988 5970989 5970990 5970991 5970992 5970993 5970994 5970995 5970996 5970997 5970998 5970999 5971001 5977372 5986111 5986112