510(k) · Cleared
ClearedQfix Radiotherapy Chair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wfr/Aquaplast Corp. · JAI Couch, Radiation Therapy, Powered
Cleared on Jun 20, 2012 after an 85-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 20, 2012
- Review
- 85 days
- Class
- Class II
- Product code
- JAI
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JAI device
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What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JAI devicesJAI Couch, Radiation Therapy, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JAI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JAI
61in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAI
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAI
1in 2024
MAUDE reports naming product code JAI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 1 | 4 |
| 2008 | 0 | — | 2 | 2 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 2 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 61 | 0 | 2 |
| 2013 | 1 | — | 2 | 5 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 1 | — | 1 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 2 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (127 words)
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).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K120916 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120916: Qfix Radiotherapy Chair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120916
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026