# K172168: WillCeph

- Pathway: 510(k) (Traditional)
- Applicant: Hdx Will Corp.
- Decided: Mar 21, 2018 after 246 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: 6 generations back to K930527 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131348: Ortomed, Infomed Servicios Informaticos S.L. (2014) Summary page 5.

## Indications for use
WillCeph is intended for use by specialized dental practices for capturing, storing and presenting patient images and radiographs and to aid in cephalometric analysis, orthodontic and orthognathic treatment planning and case follow-up. Results produced by the software tools are to be interpreted by trained and licensed dental practitioners.

Source page: https://510kreport.com/device/K172168
Methodology: https://510kreport.com/methodology
