# K151837: CS 3D Imaging

- Pathway: 510(k) (Traditional)
- Applicant: Trophy
- Decided: Aug 19, 2015 after 44 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 3D Imaging is digital imaging software intended to be used with Carestream’s 3D extra-oral X-ray equipment by healthcare professionals to display, make measurement, print, export and store 2D and 3D views of digital images of the dento-maxillofacial and ENT (Earn, Nose and Throat) region of the human anatomy as diagnostic support. It is also a software application used for the management of the implant library and the virtual placement of dental implants. It can be used as stand-alone software in a standard computer and does not perform any radiographic image acquisition.

Source page: https://510kreport.com/device/K151837
Methodology: https://510kreport.com/methodology