# K120975: CS 8100 CS 8100 Access

- Pathway: 510(k) (Traditional)
- Applicant: Trophy
- Decided: Jun 22, 2012 after 81 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Jan 8, 2015 · Class II · Z-1377-2015: Units device head descended unexpectedly

## Indications for use
The CS 8100 Access and CS 8100 are intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dlento-maxillo-facial region of the human anatomy as diagnostic support for pediatric and adult patient. In addition, the CS 3100 is provided with a 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 acquired during an exam;

Source page: https://510kreport.com/device/K120975
Methodology: https://510kreport.com/methodology