# K241819: CephNinja

- Pathway: 510(k) (Traditional)
- Applicant: Cyncronus, LLC
- Decided: Jan 23, 2025 after 213 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 K110430 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190162: SmartCeph, Ortho2, LLC (2019) Summary page 5.

## Indications for use
CephNinja software is designed for use by dental practices for cephalometric tracing and presenting patient images which are utilized by dental professionals to assist in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed practitioners. Mobile application is not for diagnostic use.

Source page: https://510kreport.com/device/K241819
Methodology: https://510kreport.com/methodology