# K120916: Qfix Radiotherapy Chair

- Pathway: 510(k) (Traditional)
- Applicant: Wfr/Aquaplast Corp.
- Decided: Jun 20, 2012 after 85 days
- Product code: JAI (Couch, Radiation Therapy, Powered)
- Device class: 2
- Regulation: 21 CFR 892.5770
- 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
The Qfix Radiotherapy Chair is designed as a support and fixation device for patients undergoig radiotherapy treatment(s). Its design includes multiple adjustments on the device to accommodate patients of varying sizes. It is designed to interface with a robotic znulti-ayis armi by way of standard (oILthe shelf) robotic tooling changeas. It incorporates the use of a kVue IGRTeouchtop insert (K060671 The device includes a Qfix One TauchTM mcchnnism for kVue Couchiop Insert insertion and ror thle ability to use other inserts for various treatment and fixation styles. The Qflx Radiotherapy Chair will also he able tu accommnodate the use of the Qfix Accubite T"' bite block stabilization system along with an array of WER/.Aquaplast masks (K935067) to assist in the fixation of the patienit during said treatmnent(s).

Source page: https://510kreport.com/device/K120916
Methodology: https://510kreport.com/methodology