# K073704: I-Dixel

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: Feb 21, 2008 after 52 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- 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.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030450: 3D Accu-I-Tomo Xyz Slice View Tomograph, J. Morita USA, Inc. (2003) Summary page 2.
- (no number) N-Liten (incorporated into ProMax 3D): named in the summary without a submission number

## Indications for use
i-Dixel is a software for management of images obtained from x-ray imaging equipment and other imaging modalities. i-Dixel is used for medical and dental image examination and diagnosis. The software is to be operated and used by doctor, dentists and other legally qualified professionals.

Source page: https://510kreport.com/device/K073704
Methodology: https://510kreport.com/methodology