# K132773: Sidexis 4

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Dec 11, 2013 after 97 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: 7 generations back to K954874 (1996). 42 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013659: Modification to Sidexis Digital Radiography Imaging System, Sirona Dental Systems GmbH (2001)
- K113543: ONDEMAND3D, Cybermed, Inc. (2011) Summary page 2.

## Cited in the summary but kept off the family tree
- K012307: Luxacore/Luxacore Dual, Dmg USA, Inc. (2001). Our reading of the summary gave K012307, FDA’s number for Luxacore/Luxacore Dual (Dmg USA, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “GALAXIS (GALILEOS family)”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K250755: DS Core Diagnosis (2025), 0 descendants of its own

## Indications for use
SIDEXIS 4 is software that offers functions for the acquisition, administration, analysis, diagnosis, presentation and transfer of digital or digitized image data, e.g. X-ray images or video recordings, for medical use, predominantly in dentistry.

Source page: https://510kreport.com/device/K132773
Methodology: https://510kreport.com/methodology