# K190162: SmartCeph

- Pathway: 510(k) (Traditional)
- Applicant: Ortho2, LLC
- Decided: Oct 17, 2019 after 259 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K241819: CephNinja (2025), 0 descendants of its own

## Indications for use
SmartCeph 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 dental practitioners.

Source page: https://510kreport.com/device/K190162
Methodology: https://510kreport.com/methodology