# K090431: Dexis Software

- Pathway: 510(k) (Traditional)
- Applicant: Dexis, LLC
- Decided: Jun 22, 2009 after 123 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: 5 generations back to K930527 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962631: Dexis Model 601 Dental Electronic Imaging System, Fair Image, Inc. (1996) Summary page 1.
- K060178: Vix Win Pro, Gendex Dental Systems (2006) Summary page 1.

## Indications for use
The DEXIS software is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement and saving of X-ray digital images from digital imaging systems. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from intra-oral and extra-oral dental cameras.

Source page: https://510kreport.com/device/K090431
Methodology: https://510kreport.com/methodology