Pure Global

GE Xeleris 4 DR Processing & Review Workstation - HSA Registration DE0503925

Access comprehensive regulatory information for GE Xeleris 4 DR Processing & 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 DE0503925 and owned by GE Medical Systems Israel, Functional Imaging. The device was registered on December 11, 2019.

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0503925
GE Xeleris 4 DR Processing & Review Workstation
HSA Registration Number: DE0503925
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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. Xeleries 4 DR covers the following applications: DaTQUANT, Q.Lung, Q.Brain and Alcyone CFR

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0503925
Registration Date
December 11, 2019
Change Notification Approval Date
June 16, 2023
Retention Due Date
December 10, 2025
Product Owner
Short Name
GE Medical Systems Israel, Functional Imaging
Address
4 Hayozma Street, Tirat Hacarmel, 30200 ISRAEL, ISRAEL
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)
Xeleris 4 DR Processing and Review Workstation Clinical Application Xeleris 4 DR Processing and Review Workstation
Model Identifier(s)
H3904CR H3904CS