# K213263: OnyxCeph

- Pathway: 510(k) (Traditional)
- Applicant: Image Instruments GmbH
- Decided: Jan 4, 2023 after 461 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)
- K053010: Vistadent at Complete, Model 3.1, Dentsply Intl., Inc. (2005) Summary page 4.

## Indications for use
Onyx:Ceph3TM software is intended to be used for the medical purpose of managing and evaluating two-dimensional and three-dimensional images in the framework of digital orthodontics by qualified staff only. The use of Onyx:Ceph3 ™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software. The software can be used to digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data.

Source page: https://510kreport.com/device/K213263
Methodology: https://510kreport.com/methodology