# K243005: AudaxCeph Cephalogram Analysis Software

- Pathway: 510(k) (Traditional)
- Applicant: Audax D.O.O.
- Decided: May 30, 2025 after 246 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 10 generations back to K930527 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231396: CEPHX- Cephalometric Analysis Software, Orca Dental AI, Ltd. (2024) Summary page 5.

## Indications for use
AudaxCeph Cephalogram Analysis Software is designed for use by specialized dental practices for storing and presenting patient images and assisting in treatment planning. Results produced by the software's treatment planning tools are dependent on the interpretation of trained and licensed practitioners.

Source page: https://510kreport.com/device/K243005
Methodology: https://510kreport.com/methodology