# K092479: SDX-Spirodynr'x Radiotherapy Breathing Control

- Pathway: 510(k) (Traditional)
- Applicant: Dyn'R
- Decided: Jan 11, 2010 after 151 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: 1 generation back to K003330 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003330: Aktina Medical Physics Corporation Active Breathing Coordinator (Abc), Aktina Medical Physics Corp. (2001) Summary page 1.

## Most influential descendants
- K121845: SDX System (2012), 0 descendants of its own

## Indications for use
SDX - 'SpiroDynr’X 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 the time when a breath should be held to limit internal motion during treatment.

Source page: https://510kreport.com/device/K092479
Methodology: https://510kreport.com/methodology