GE HUALUN Medical Systems Xeleris 4.0 Processing and Review Workstation - HSA Registration DE0018702
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.
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.