Xeleris V Processing and Review Systems
GE HealthcareXeleris V Processing and Review System is a nuclear medicine software platform that helps physicians process, review, and quantify medical images from nuclear medicine, PET, and associated CT or MR scans. It supports multiple clinical applications including detection of brain diseases, lung conditions, coronary artery disease, and bone metastases, using AI-based image analysis such as deep learning for automated segmentation to enhance workflow efficiency and accuracy.
Intended Use
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 and tomographic scans acquired by gamma cameras or PET scanners. It supports multimodality imaging fusion with CT or MR and allows depiction, localization, and quantification of radionuclide tracer distribution and anatomical structures for clinical diagnostic purposes.
Technology
Xeleris V operates on dedicated workstations or server-client configurations and provides digital processing, image manipulation, visualization, segmentation, and quantification capabilities. It introduces two new deep learning-based segmentation algorithms for lung fissure and kidney segmentation while maintaining functionalities for multimodal image fusion, automatic and manual processing workflows, and clinical application-specific analyses.
Performance
The software underwent comprehensive design control, software verification and validation per industry standards (NEMA, IEC62304) under a quality management system. Clinical performance testing included algorithm evaluation on representative test datasets by experienced physicians and physicists, demonstrating safe and effective operation with no new safety concerns. Clinical studies were not required due to substantial equivalence to predicate device and successful bench and clinical testing data.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/24/2020
5 months - 2
FDA Approval
9/25/2020
Other devices from GE Healthcare
- Precision DL2023 • 510K
- Xeleris V Processing and Review System2023 • 510K
- Voluson P6, Voluson P82022 • 510K
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