# K121845: SDX System

- Pathway: 510(k) (Traditional)
- Applicant: Dyn'R Sas
- Decided: Oct 19, 2012 after 116 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K864886 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102024: RPM Respiratory Gating System, Varian Medical Systems (2010) Summary page 1.
- K092479: SDX-Spirodynr'x Radiotherapy Breathing Control, Dyn'R (2010) Summary page 3.

## Indications for use
SDX is intended for use in Radiation therapy as an aid in allowing the patient and treatment staff to visualize a patients breathing process and to optimize breathing to limit internal motion during imaging & treatment. The SDX System including the Automatic Gating Module is used to provide respiratory synchronization for radiation therapy imaging & treatment. The SDX System may be used for pediatric, adolescents & adult patients above the age of 5 years capable of understanding and following the radiotherapists instructions.

Source page: https://510kreport.com/device/K121845
Methodology: https://510kreport.com/methodology