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Singapore HSA registration DE0509752

GE AW Volumeshare 7

Singapore flagSingapore·CLASS C·GE Medical Systems SCS·Registered September 09, 2024
Device classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0509752
Registration Date
September 09, 2024
Retention Due Date
September 08, 2025
Product description
AW VolumeShare 7 is a review workstation, which allows easy selection, review, processing and filming of multi–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.
Product Owner
Name
GE Medical Systems SCS
Short Name
GE Medical Systems SCS
Address
283 Rue De La Miniere, 78530 Buc, FRANCE
Registrant
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Name
GE HEALTHCARE PTE. LTD.
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 SmartScore 4.0 Advantage 4D Advantage 4D SW and Docs for AW Workstation CardiacVX CardiacVX SW & Docs for AW Workstation CardiacVX Flow CardiacVX StarMap 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 AW VolumeShare 7 Advantage Paste Quantib Brain SW and Docs for AW Workstation Quantib Brain MAGiC MAGiC SW and Docs for AW Workstation 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
Model Identifier(s)
2357634-12 2357636-14 5196876-23 5400055-13 5400057-8 5434384-10 5434388-11 5434389-10 5434391-10 5479284-9 5479285-7 5480372-7 5483148-7 5486302-7 5694566 5729630 5737000-5 5737002-5 5747598-5 5747629-4 5778788-8 5778797-8 5782582-2 5789396-3 5789424 5789425 5789426 5789427
About this record

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 DE0509752 and owned by GE Medical Systems SCS. The device was registered on September 09, 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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