# K103182: Triana, Picture Archiving and Communications System

- Pathway: 510(k) (Traditional)
- Applicant: Genoray Co., Ltd.
- Decided: Jan 14, 2011 after 78 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 K954678 (1996). 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)
- K070464: ONDEMAND3D, Cybermed, Inc. (2007) Summary page 1.

## Indications for use
Triana is intended for use as a software package which obtains medical images from CT, Cephalomnetric / Panoramic X-ray system & etc., stores those and provides 3D visualization, 2D analysis, various MPR(Multi-Planar Reconstruction) functions for further rapid and precise diagnosis.

Source page: https://510kreport.com/device/K103182
Methodology: https://510kreport.com/methodology