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Singapore HSA registration DE0509228

GE Xeleris V

Singapore flagSingapore·CLASS B·GE Medical Systems Israel, Functional Imaging·Registered April 25, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0509228
Registration Date
April 25, 2024
Retention Due Date
April 24, 2026
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 in 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. Xeleris V covers the following applications: DaTQUANT, Q.Lung AI, Q.Brain, Alcyone CFR, Q.Liver, EXINI Bone and Q.Thera AI.
Product Owner
Name
GE Medical Systems Israel, Functional Imaging
Short Name
GE Medical Systems Israel, Functional Imaging
Address
4 Hayozma Street, Tirat Hacarmel, 30200 ISRAEL, ISRAEL
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)
Xeleris V Processing and Review System
Model Identifier(s)
195278822383
About this record

Access comprehensive regulatory information for GE Xeleris V in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509228 and owned by GE Medical Systems Israel, Functional Imaging. The device was registered on April 25, 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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