# K150382: Radio Therapy Treatment Chair

- Pathway: 510(k) (Traditional)
- Applicant: Radiation Products Design, Inc.
- Decided: Sep 16, 2015 after 210 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
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.

## Indications for use
This versatile Treatment Chair provides upright positioning for specialty treatment cases of head, neck, thorax, breast and lung or for patients who have difficulty lying supine for treatments. The seated patient has improved comfort increased lung volume and reduced respiratory motion. The treatment chair will be used on Medical Linear Accelerator treatment couch located in a hospital or clinic. A physician and physicist will prescribe its use for a treatment on a patient. "Caution Federal law (USA) restricts the sale of this device for use only by (or at the order of) a physician." THE TREATMENT CHAIR IS NOT STERILE AND IS TO BE USED BY HOSPITAL OR CLINICAL AUTHORIZED PERSONEL ONLY.

Source page: https://510kreport.com/device/K150382
Methodology: https://510kreport.com/methodology