Singapore HSA registration DE0509633
GE AW Server 3.2
Singapore·CLASS B·GE Medical Systems SCS·Registered August 07, 2024Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0509633
- Registration Date
- August 07, 2024
- Retention Due Date
- August 06, 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.
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 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 cvi42 cvi42 SW and Docs for AW Workstation and AW Server SmartScore SW and Docs for for AW Workstation and AW Server SmartScore 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 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 CT Perfusion 4D BreView CardIQ Suite
- 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 5778788-8 5778797-8 5828722-2 5926357 5934724 5934725 5934726 5934727 5934728 5934729 5934730 5934731 5934732 5934733 5934736 5934737 5934738 5934739 5934740 5934741 5934742 5934743 5934744 5934745 5934746 5934747 5934748 5934749 5934750 5934751 5934752 5934753 5934754 5934755 5934756 5934757 5934758 5940383 5942367 5942454
About this record
Access comprehensive regulatory information for GE AW Server 3.2 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509633 and owned by GE Medical Systems SCS. The device was registered on August 07, 2024.
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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