# K113421: Minicat

- Pathway: 510(k) (Special)
- Applicant: Xoran Technologies, Inc.
- Decided: Jul 11, 2012 after 236 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K973598 (1997). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032243: Minicat Dentocat, Xoran Technologies, Inc. (2003) Summary page 1.

## Most influential descendants
- K210257: Xoran Workstation, Model 10050 (2021), 0 descendants of its own

## Recalls of this device
- Sep 8, 2014 · Class II · Z-1210-2015: Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.

## Indications for use
The MiniCAT is an X-ray imaging device that constructs a three dimensional model of the head and neck from images taken during a rotational X-ray sequence. The MiniCAT is optimized for the imaging of the maxillofacial complex, temporal bone, sinuses, and for neuro-angiography.

Source page: https://510kreport.com/device/K113421
Methodology: https://510kreport.com/methodology