# K073695: 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1F8/F17

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: Apr 9, 2008 after 100 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). 5 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052587: 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf, J. Morita USA, Inc. (2005) Summary page 2.

## Most influential descendants
- K110839: Scanora 3D (2011), 4 descendants of its own
- K163423: Orthopantomograph OP300 (2017), 2 descendants of its own
- K230505: Orthopantomograph™ OP 3D LX (2023), 1 descendant of its own
- K241249: Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) (2024), 0 descendants of its own
- K130297: Scanora 3DX (2013), 0 descendants of its own

## Indications for use
The Model MCT*1EX-1F8/F17 is a x'ray imaging device that acquires a 360 degree rotational sequence of the head and neck areas, including the ENT and dento*maxillofacial areas, for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two-dimensional views of this volume, displaying both two- and three* dimensional images. The device is operated and used by physicians, dentists and x-ray technologists.

Source page: https://510kreport.com/device/K073695
Methodology: https://510kreport.com/methodology