# K061284: I-Cat Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Imaging Sciences Intl., Inc.
- Decided: Jul 3, 2006 after 56 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: 2 (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). 4 ancestors in all.
31 later devices descend from it; 4 cite it directly.
0 of 36 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) Summary page 2.
- K030450: 3D Accu-I-Tomo Xyz Slice View Tomograph, J. Morita USA, Inc. (2003) Summary page 2.

## Most influential descendants
- K073350: Scanora 3D (2007), 24 descendants of its own
- K093683: Orthopantomograph OP300 (2010), 21 descendants of its own
- K111231: Panoura 18S (2011), 11 descendants of its own
- K122018: OP300 (2012), 8 descendants of its own
- K133544: OP300 (2014), 7 descendants of its own

## Recalls of this device
- Jan 8, 2009 · Not classified · Z-1265-2009: faulty calibration
- Mar 19, 2008 · Not classified · Z-1646-2008: Incorrect scatter information in the manual.

## Indications for use
The Imaging Sciences International Inc. i-CAT Scanner constructs a three dimensional model from images taken during a rotational X-ray sequence. The Imaging Sciences i-CAT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The system is designed for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, and other areas of the maxillofacial complex.

Source page: https://510kreport.com/device/K061284
Methodology: https://510kreport.com/methodology