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Singapore HSA registration DE0018702

GE HUALUN Medical Systems Xeleris 4.0 Processing and Review Workstation

Singapore flagSingapore·CLASS B·GE Hualun Medical Systems Co Ltd·Registered November 03, 2016
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0018702
Registration Date
November 03, 2016
Retention Due Date
November 02, 2025
Product description
The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NMI data, including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated SPECT, dedicated PET or Camera-Based-PET) acquired by gamma cameras or PET scanners. The system can run on a dedicated workstation or a server-client configuration. The NM or PET data can be coupled with registered and/or fused CT or MR scans, and with physiological signals in order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes. Refer to Xeleris 4.0 operator guide for indications of DaTQUANT, Q.Lung, Q.Brain and Alcyone CFR applications.
Product Owner
Name
GE Hualun Medical Systems Co Ltd
Short Name
GE Hualun Medical Systems Co Ltd
Address
No.1 Yong Chang North Road, Beijing Economic Technological, Development Zone, Beijing, 100176, CHINA
Registrant
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Name
GE HEALTHCARE PTE. LTD. GE PACIFIC HOLDINGS PTE. LTD. GE PACIFIC PRIVATE LIMITED
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model information
Model Name(s)
X4 WS Full Integrated X4 WS Full Standalone X4 WS Full Additional
Model Identifier(s)
H2403AJ H2403AK H2403AL
About this record

Access comprehensive regulatory information for GE HUALUN Medical Systems Xeleris 4.0 Processing and Review Workstation in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018702 and owned by GE Hualun Medical Systems Co Ltd. The device was registered on November 03, 2016.

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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