# K151087: CS 8100SC, CS8100SC Access

- Pathway: 510(k) (Traditional)
- Applicant: Trophy
- Decided: Aug 21, 2015 after 120 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- 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
The CS 8100SC and the CS 8100SC Access are intended to produce complete or segmented tomographic digital panoramic and cephalometric digital X-ray images to be used at the direction of healthcare professionals of the dento-maxillofacial region of the human anatomy as diagnostic support for pediatric and adult patients. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment. In addition, the CS 8100SC is provided with the panoramic radiological exam option which allows the display of one determined segment of the dental structures using the capability of the system to explore each slice during an exam.

Source page: https://510kreport.com/device/K151087
Methodology: https://510kreport.com/methodology