510(k) · Cleared
ClearedKvue Igrt Treatment Table Top, RT-4551KV, Kvue Inserts and Accessories, Various
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 May 4, 2006 after a 51-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- May 4, 2006
- Review
- 51 days
- Class
- Class II
- Product code
- JAI
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060671 | Kvue Igrt Treatment Table Top, RT-4551KV, Kvue Inserts and Accessories, Various | Wfr/Aquaplast Corp. | 2006 | — |
| +1 | K161400 | ImagingRing System | Medphoton GmbH | 2016 | — |
| +2 | K191267 | ImagingRing System on Rails | Medphoton GmbH | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
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
- #1 K231612 Eve Patient Positioner Systemscore 7.9 · 3 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161400 | ImagingRing System | 2016 | 1 |
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.
What does this lineage say?
- Of its descendants, K161400 (Medphoton GmbH, 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JAI devicesJAI Couch, Radiation Therapy, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 kVue IGRT Treatment Table Top, inserts, and accessories are designed to position and support patients undergoing radiation therapy. The kVue Treatment Table Top is designed to replace an original equipment manufacturer's stock table top. The Qfix kVue Patient Positioning Table Top and inserts are made using sliding beams and advanced fiber composites that contain no metal parts in the treatment area, thus allowing the devices to be used in various…
Read the full statement (177 words)
The kVue IGRT Treatment Table Top, inserts, and accessories are designed to position and support patients undergoing radiation therapy. The kVue Treatment Table Top is designed to replace an original equipment manufacturer's stock table top. The Qfix kVue Patient Positioning Table Top and inserts are made using sliding beams and advanced fiber composites that contain no metal parts in the treatment area, thus allowing the devices to be used in various diagnostic and treatment modalities without fear of interference caused by metal parts. In particular these devices are designed for optimal performance when used with on board imaging and cone beam CT while simultaneously reducing beam attenuation for treatments that pass through the couch. The kVue inserts include the Cantilever Board insert, the Quest Breast Board insert, the prone breast board insert, the Qfix Pelvis/Belly Board insert, the Box Grid insert, the Solid Panel insert, the Center Spine insert, the DoseMax insert, and the removable tip extension. kVue accessories include the device adapter bar, the VacuFix Bags, the removable clamp rail, and the removable tip extension hardware.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K060671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060671: Kvue Igrt Treatment Table Top, RT-4551KV, Kvue Inserts and Accessories, Various.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060671
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026