# K103659: CS 9300, CS 9300C

- Pathway: 510(k) (Traditional)
- Applicant: Trophy
- Decided: Aug 18, 2011 after 246 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K160506: Planmeca ProMax 3D Max, Planmeca Maximity (2016), 7 descendants of its own
- K122199: PREXION3D Eclipse (2013), 6 descendants of its own
- K181576: Planmeca Viso (2018), 4 descendants of its own
- K230985: Planmeca Viso (2023), 3 descendants of its own
- K161881: PreXion3D Excelsior (2016), 2 descendants of its own

## Indications for use
The CS 9300 and CS 9300C are systems intended to produce two-dimensional and three-dimensional digital x-ray images of the dento-maxillo-facial, and ENT (Ear, Nose and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients. In addition, the CS 9300C is intended to produce cephalometric images. This includes imaging the hand and wrist to obtain the carpus image for growth and maturity assessment.

Source page: https://510kreport.com/device/K103659
Methodology: https://510kreport.com/methodology