Pure Global AI
HSA · registration DE0510658

AW Server 3.2

SingaporeRadiology / ImagingClass CGE Medical Systems SCS
Official record identity
Registration number
DE0510658
Model name
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
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
Registration date
May 01, 2025
Classification
Risk class
Class C
Official value: CLASS C
Published category
Radiology / Imaging
Published parties
Official 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.

Additional source fields
Product owner address
293, Rue de la Miniere, 78530 BUC, France
Registrant address
11 North Buona Vista Drive, #11-07, The Metropolis, Singapore 138589
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.