# K113419: CS Imaging

- Pathway: 510(k) (Traditional)
- Applicant: Trophy
- Decided: Feb 16, 2012 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
CS Imaging software is intended to be used with Carestream's dental digital imaging systems by healthcare professionals to display, adjust, measure, print and store 2D digital images of the dento-maxillofacial region of the human anatomy to support image diagnosis.

Source page: https://510kreport.com/device/K113419
Methodology: https://510kreport.com/methodology