# K130884: Xeleris 3.1 Processing and Review Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems F.I. Haifa
- Decided: Apr 12, 2013 after 14 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: 8 generations back to K010641 (2001). 21 ancestors in all.
77 later devices descend from it; 6 cite it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093982: Xeleris 3 Processing and Review Workstation, Ge Medical Systems F.I. Haifa (2010) Summary page 2.
- K021656: Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4, Nuclear Diagnostics (2002) Summary page 2.
- K123528: Scenium, Siemens Medical Solutions USA, Inc. (2012) Summary page 2.

## Most influential descendants
- K153355: Xeleris 4.0 Processing and Review Workstation (2016), 60 descendants of its own
- K182624: MIM - MRT Dosimetry (2018), 53 descendants of its own
- K191928: AccuContour (2020), 30 descendants of its own
- K140269: Hermes Medical Imaging Suite V5.4 (2014), 15 descendants of its own
- K190379: MIM on Linux (2019), 14 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 NM 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 mun 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. DaTQUANT optional application enables Visual evaluation and quantification of ' 231I loflup.ane (DaTscan TM ) images. DaTQUJANT Normal Database option enables quanrtification relative to normal population databases of 123I-ioflupane (DaTscan mT-) images. These applications may assist in detection of loss of functional dopaminergic neuron terminals in the striatum., which is correlated with Parkinson disease.

Source page: https://510kreport.com/device/K130884
Methodology: https://510kreport.com/methodology