# K161270: CephSimulation

- Pathway: 510(k) (Traditional)
- Applicant: Anatomage, Inc.
- Decided: Jan 4, 2017 after 244 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: 1 generation back to K110430 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110430: Dolphin Imaging, Patterson Dental Supply, Inc. (2011) Summary page 4.

## Indications for use
CephSimulation is a software application intended for storing and visualization of patient images and assisting in case diagnosis and surgical treatment planning. Results of the software are to be interpreted by trained and licensed dental and medical practitioners. It is intended for use by dentist, medical surgeons, and other qualified individuals using a standard PC. This device is not indicated for mammography use.

Source page: https://510kreport.com/device/K161270
Methodology: https://510kreport.com/methodology