HSA · registration DE0510654GE Xeleris V
- Registration number
- DE0510654
- Model name
- Xeleris V Processing and Review System
- Model identifier
- 00195278614933
- Registration date
- April 30, 2025
- Risk class
- Class B
- Product owner
- GE Medical Systems Israel
- Registrant / registration holder
- GE HEALTHCARE TECHNOLOGIES PACIFIC PRIVATE LIMITED
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 address
- Functional Imaging, 4, Hayozma Street, Tirat Hacarmel 30200, Israel
- Registrant address
- 11 North Buona Vista Drive, #11-07, The Metropolis, Singapore 138589
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.