# K051673: Xeleris 2 Processing and Review Workstation

- Pathway: 510(k) (Special)
- Applicant: GE Medical Systems
- Decided: Jul 18, 2005 after 25 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000395 (2000). 2 ancestors in all.
192 later devices descend from it; 7 cite it directly.
0 of 195 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024137: Jupiter Processing and Review Workstation, Ge Medical Systems, Inc. (2003) Summary page 1.

## Most influential descendants
- K093982: Xeleris 3 Processing and Review Workstation (2010), 134 descendants of its own
- 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

## Recalls of this device
- Oct 6, 2011 · Class II · Z-1164-2013: GE Healthcare has become aware of a software issue in your Xeleris 2.1 workstation (that is used for processing Discovery 530/570 data), that may impact patient safety. On imported CT scans, Myocardia
- 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
- Oct 27, 2010 · Not classified · Z-0537-2011: GE Healthcare has become aware of inaccurate user protocol setup associated with the Thyroid Uptake Index application on certain Xeleris workstations(1.0, 1.1, 2.0, 2.1) that may impact patient safety

## Indications for use
The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration.

Source page: https://510kreport.com/device/K051673
Methodology: https://510kreport.com/methodology