Xeleris V Processing and Review System
GE HealthcareThe Xeleris V Processing and Review System by GE Healthcare is a software platform designed for processing, reviewing, and analyzing nuclear medicine and PET imaging data. It supports various clinical applications including brain, lung, cardiac, liver, and bone imaging analyses, aiding physicians in diagnosis and treatment planning by providing enhanced image visualization, quantification, and monitoring of patient radiation doses.
Intended Use
System intended for use by Nuclear Medicine or Radiology practitioners and referring physicians for processing, display, archiving, printing, reporting, and networking of nuclear medicine imaging data from planar and tomographic scans, sometimes coupled with CT or MR scans, to assist clinical diagnostic purposes across multiple applications including dopaminergic neuron terminal loss, pulmonary diseases, brain disorders, coronary artery disease, bone metastases, liver therapy planning, and radiation dose monitoring.
Technology
The system provides digital processing, review, and reporting of nuclear medicine images including data display, quality control, image manipulation and quantification analysis, transfer, storage, and printing. It operates on dedicated workstations or in client-server configurations. It introduces new applications Q.Thera AI for radiation dose calculations following MIRD and ICRP guidelines, and Generate Planar for producing 2D planar images derived from 3D SPECT images. Core functions include manual and automatic segmentation, image registration, and quantification for diagnostic support.
Performance
The device underwent extensive design control testing including software verification and validation per relevant standards NEMA PS3.1-3.20 and IEC62304. Bench testing demonstrated the correctness of radiation dose calculations and similarity of generated planar images from SPECT-only versus SPECT-CT studies. Clinical studies were not required; bench testing using representative clinical datasets sufficed to confirm safety and effectiveness. Risk management and quality system usage identified no new safety concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/9/2022
8 months - 2
FDA Approval
3/1/2023
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