# K200183: CS 9600

- Pathway: 510(k) (Traditional)
- Applicant: Trophy
- Decided: Mar 13, 2020 after 49 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K973598 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181136: CS 9600, Trophy (2018) Summary page 5.

## Recalls of this device
- Jul 21, 2021 · Class II · Z-1627-2023: Device failed to function as intended and/or failed to conform to their design specifications.

## Indications for use
The CS 9600 is extraoral system intended to produce two-dimensional and three-dimensional digital X-ray images of the dento-maxillofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients. The CS 9600 can be upgraded to produce cephalometric digital X-ray images. This includes imaging the hand and wrist to obtain carpus image for growth and maturity assessment.

Source page: https://510kreport.com/device/K200183
Methodology: https://510kreport.com/methodology