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GE AW Volumeshare 7 - HSA Registration DE0508336

Access comprehensive regulatory information for GE AW Volumeshare 7 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508336 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
DE0508336
GE AW Volumeshare 7
HSA Registration Number: DE0508336
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Product Description

AW VolumeShare 7 is a review workstation, which allows easy selection, review, processing and filming of multiโ€“modality DICOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed or displayed images on the AW monitor may be used as a basis for diagnosis, except in the case of mammography images.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0508336
Registration Date
July 27, 2023
Retention Due Date
July 26, 2025
Product Owner
Short Name
GE Medical Systems SCS
Address
283 RUE DE LA MINIERE, 78530 BUC FRANCE, 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)
Dentascan SW and Docs for AW Workstation Dentascan Cardiac X-ray Analysis CardIQ Physio SW & Docs for AW Workstation CardIQ Physio SmartScore 4.0 Gemstone Spectral Imaging (GSI) Viewer Advantage 4D Advantage 4D SW and Docs for AW Workstation CardiacVX CardiacVX SW & Docs for AW Workstation CardiacVX Flow CardiacVX StarMap AdvantageSim MD CT atlas-based contouring and re-planning AdvantageSim MD 9.0 AdvantageSim MD MR pelvic organ at risk segmentation AdvantageSim MD SW and Docs for AW Workstation AngioViz CortexID Suite CortexID Suite SW & Docs for for AW Workstation CardIQ Xpress Process SW and Docs for AW Workstation and AW Server CardIQ Xpress Process MR Pasting Gemstone Spectral Imaging (GSI) Viewer SW and Docs for AW Workstation AW 4.7 SW and Docs Advantage Paste Quantib Brain SW and Docs for AW Workstation Quantib Brain MAGiC MAGiC SW and Docs for AW Workstation 3DXR 3D CT 3DXR SW and Docs for AW Workstation 3D CT HD MAR 3D CT HD Motion Freeze 3D CT HD Active Tracker 3DXR 3D CT HD cvi42 cvi42 SW and Docs forAW Workstation and AW Server MR Pasting SW and Docs for AW Workstation Brainwave Performance BrainWave Adv Visualization BrainWave Adv DTI Tracking BrainWave Struct Reporting Brainwave Fusion Perf BrainWave Skull Stripping Brainwave Resting State BrainWave Tract Generation Cardiac Xray Analysis SW & Docs for AW Workstation SnapShot Freeze 2 SnapShot Freeze 2 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 AW VolumeShare 7 SW BrainWave SW and Docs for AW Workstation DyanmicIQ AW 4.7 Full SW and Docs Set Vision 2 TrackVision 2 HeartVision 2 EVARVision READY View Liver Suite SmartScore 4.0 SW and Docs for for AW Workstation and AW Server FlightPlan for Embolization
Model Identifier(s)
2357634-12 2357636-14 2390482-15 5182715-10 5189543-10 5196876-23 5342114-14 5400055-13 5400057-8 5434384-9 5434388-10 5434389-9 5434391-9 5452895-8 5456133-15 5456208-8 5462238-11 5474315 5479284-9 5479285-7 5480372-7 5483148-7 5486302-7 5694435-2 5694566-38 5729630 5737000-4 5737002-4 5747598-4 5747629-3 5774806-2 5774810-2 5775391 5775395 5775408 5776614-2 5778788-7 5778797-7 5782582-2 5789396-3 5789424 5789425 5789426 5789427 5789428 5789429 5789430 5799855-3 5807631 5826290-3 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 5860803-6 5879086 5882427 5883175-3 5884027 5884028 5884029 5884030 5890197 5918502 5926357 5927105