# K221680: Xeleris V Processing and Review System

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Mar 1, 2023 after 265 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K010641 (2001). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201103: Xeleris V Processing and Review Systems, GE Healthcare (2020) Summary page 6.

## Most influential descendants
- K241350: Clarify DL (2025), 0 descendants of its own

## Indications for 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 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 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. The DaTQUANT optional application enables visual evaluation and quantification of 123I-ioflupane (DaTscanTM) images. DaTQUANT Normal Database option enables quantification relative to normal population databases of 123I-ioflupane (DaTscanTM) images. These applications may assist in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease. The Q.Lung AI application may aid physicians in: - Diagnosis of Pulmonary Embolism (PE), Chronic Obstructive Pulmonary Disease (COPD), Emphysema and other lung deficiencies. - Assess the fraction of total lung function provided by a lobe or whole lung for Lung cancer resection requiring removal of an entire lobe, bilobectomy, or pneumonectomy. The Q.Brain application allows the user to visualize and quantify relative changes in the brain’s metabolic function or blood flow activity between a subject’s images and controls, which may be resulting from brain function alterations in: - Epileptic seizures - Dementia. Such as Alzheimer’s disease, Lewy body dementia, Parkinson’s disease with dementia, vascular dementia, and frontotemporal dementia. - Inflammation - Brain death - Cerebrovascular disease such as Acute stroke, Chronic and acute ischemia - Traumatic Brain Injury (TBI) When integrated with the patient’s clinical and diagnostic information, Q.Brain application may aid the physician in the interpretation of cognitive complaints, neuro-degenerative disease processes and brain injuries. The Alcyone CFR application allows for the quantification of coronary vascular function by deriving Myocardial Blood Flow (MBF) and then calculating Coronary Flow Reserve (CFR) indices on data acquired on PET scanners and on stationary SPECT scanners with the capacity for dynamic SPECT imaging. These indices may add information to physicians using Myocardial Perfusion Imaging for the diagnosis of Coronary Artery Disease (CAD). The Exini Bone application is intended to be used with NM bone scans for the evaluation of adult male patients with bone metastases from prostate cancer. Exini Bone quantifies the selected lesions and provides a Bone Scan Index value as adjunct information related to the progression of disease. The Q.Liver application provides processing, quantification, and multidimensional review of Liver SPECT/PET and CT images for display, segmentation, and a calculation of the SPECT ‘liver to lung’ shunt value and the patient’s Body Surface Area (BSA) for use in calculating a therapeutic dose for Selective Internal Radiation Therapy (SIRT) treatment using a user defined formula. The Q.Thera AI application allows physicians review and monitor patient radiation doses derived from nuclear medicine imaging data, including SPECT/CT, PET/CT, and Whole-body Planar images, and from biological samples from the patient. The application provides estimates of isotope residence time, absorbed dose, and equivalent dose at the whole organ level, as well as estimates of whole-body effective dose. The output from Q.Thera AI may aid physicians in monitoring patient radiation doses. For use with internally administered radioactive products. Q.Thera AI should not be used to deviate from approved product dosing and administration instructions. Refer to the product's prescribing information for instructions.

Source page: https://510kreport.com/device/K221680
Methodology: https://510kreport.com/methodology