# K061834: Xcat; Xcat for Neuro

- Pathway: 510(k) (Traditional)
- Applicant: Xoran Technologies, Inc.
- Decided: Aug 7, 2006 after 39 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K973598 (1997). 13 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051765: Ceretom, Model NL3000, Neurologica Corporation (2005) Summary page 2.
- K032243: Minicat Dentocat, Xoran Technologies, Inc. (2003) Summary page 2.

## Most influential descendants
- K143435: Planmed Verity (2015), 2 descendants of its own
- K121418: Planmed Verity (2013), 2 descendants of its own
- K180918: Planmed Verity (2018), 1 descendant of its own
- K160723: OnSight 3D Extremity System (2016), 1 descendant of its own
- K252249: Extremity CT Imaging System (2026), 0 descendants of its own

## Indications for use
The XCAT is intended to be used for x-ray computed tomography imaging of anatomy that safely fits into the imaging gantry (such as the head, neck, wrist, ankle, hand and foot).

Source page: https://510kreport.com/device/K061834
Methodology: https://510kreport.com/methodology