# K032243: Minicat Dentocat

- Pathway: 510(k) (Traditional)
- Applicant: Xoran Technologies, Inc.
- Decided: Oct 2, 2003 after 72 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K973598 (1997). 5 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003787: Newtom QR-DVT 9000, Aperio Services, LLC (2001)
- K945375: Advantx Lca, GE Medical Systems (1995)
- K030450: 3D Accu-I-Tomo Xyz Slice View Tomograph, J. Morita USA, Inc. (2003)

## Most influential descendants
- K061834: Xcat; Xcat for Neuro (2006), 6 descendants of its own
- 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

## Recalls of this device
- Sep 17, 2008 · Not classified · Z-0561-2010: The system may overheat, causing poor image quality, interruption in image acquisition and/or damage to the system. Also, if the system is not allowed to cycle down prior to being restarted after an e
- Jan 4, 2008 · Not classified · Z-0826-2008: Misbranding; These devices do not bear the manufacturer's name or address.
- Jul 13, 2006 · Not classified · Z-0296-2008: The hard drive may crash, resulting in loss of data from patient CT scans.

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

Source page: https://510kreport.com/device/K032243
Methodology: https://510kreport.com/methodology