# K093982: Xeleris 3 Processing and Review Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems F.I. Haifa
- Decided: Jan 8, 2010 after 15 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000395 (2000). 3 ancestors in all.
134 later devices descend from it; 5 cite it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051673: Xeleris 2 Processing and Review Workstation, GE Medical Systems (2005) Summary page 1.

## Most influential descendants
- K130884: Xeleris 3.1 Processing and Review Workstation (2013), 77 descendants of its own
- K101228: Mirada XD (2010), 70 descendants of its own
- K153355: Xeleris 4.0 Processing and Review Workstation (2016), 60 descendants of its own
- K182624: MIM - MRT Dosimetry (2018), 53 descendants of its own
- K102687: Mirada RT (2010), 37 descendants of its own

## Recalls of this device
- Jan 12, 2011 · Not classified · Z-1250-2011: GE Healthcare has become aware of safety issues relevant for the Xeleris Workstation 1.0, 1.1, 2.0, 2.1, 3.0: 1. Measurements taken on the CT Images on the CT system are different from the Xeleris Wor

## 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 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.

Source page: https://510kreport.com/device/K093982
Methodology: https://510kreport.com/methodology