# K013659: Modification to Sidexis Digital Radiography Imaging System

- Pathway: 510(k) (Special)
- Applicant: Sirona Dental Systems GmbH
- Decided: Dec 6, 2001 after 30 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- 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 K972168 (1997). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992644: Sidexis Digital Radiography Imaging System, Sirona Dental Systems GmbH (1999) Summary page 2.

## Most influential descendants
- K132773: Sidexis 4 (2013), 1 descendant of its own
- K250755: DS Core Diagnosis (2025), 0 descendants of its own
- K081903: Xios Plus Wall-Module (2008), 0 descendants of its own

## Indications for use
SIDEXIS is a digital radiography imaging system intended to replace conventional radiographic film for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Source page: https://510kreport.com/device/K013659
Methodology: https://510kreport.com/methodology