# K231396: CEPHX- Cephalometric Analysis Software

- Pathway: 510(k) (Traditional)
- Applicant: Orca Dental AI, Ltd.
- Decided: Jan 31, 2024 after 261 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: 9 generations back to K930527 (1993). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220903: WebCeph, Assemblecircle Corp. (2022) Summary page 5.

## Most influential descendants
- K243005: AudaxCeph Cephalogram Analysis Software (2025), 0 descendants of its own

## Indications for use
CEPHX - Cephalometric Analysis Software is indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO (Visual Treatment Objective), and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists. The device is only for use on patients 14 years old and above.

Source page: https://510kreport.com/device/K231396
Methodology: https://510kreport.com/methodology