# K131348: Ortomed

- Pathway: 510(k) (Abbreviated)
- Applicant: Infomed Servicios Informaticos S.L.
- Decided: Aug 5, 2014 after 452 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: 5 generations back to K930527 (1993). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 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.
- K122427: CS Orthodontic Imaging Software CS Oms Imaging Software, Carestream Dental, LLC (2012) Summary page 4.

## Most influential descendants
- K172168: WillCeph (2018), 0 descendants of its own

## Indications for use
ORTOMED 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 surgery treatment planning and communication as well as 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/K131348
Methodology: https://510kreport.com/methodology