# K030450: 3D Accu-I-Tomo Xyz Slice View Tomograph

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: May 6, 2003 after 84 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: 1 generation back to K973598 (1997). 3 ancestors in all.
88 later devices descend from it; 6 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973598: Siremobil CO2, Siemens Medical Solutions USA, Inc. (1997) Summary page 2.
- K003266: Siremobil Iso-C 3D, Siemens Medical Solutions USA, Inc. (2000) Summary page 2.
- K003787: Newtom QR-DVT 9000, Aperio Services, LLC (2001) Summary page 2.

## Most influential descendants
- K052587: 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf (2005), 66 descendants of its own
- K060328: Planmeca Promax 3D (2006), 61 descendants of its own
- K061284: I-Cat Scanner (2006), 31 descendants of its own
- K111152: Rotograph Evo 3D (2011), 27 descendants of its own
- K122981: Rayscan a-Expert 3D (2013), 24 descendants of its own

## Indications for use
The 3D Accu-I-tom0 is an 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 can also be used for fluoroscopy during surgery, mostly for ENT and TMJ applications and mostly with a contrast medium. The device is operated and used by physicians, dentists, and x-ray technologists.

Source page: https://510kreport.com/device/K030450
Methodology: https://510kreport.com/methodology