510(k) · Cleared
Recalled · Class II · 2013Robocouch Patient Support System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accuray Incorporated · JAI Couch, Radiation Therapy, Powered
Cleared on Sep 17, 2004 after a 39-day review. The FDA summary names its predicate without a number. 7 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 17, 2004
- Review
- 39 days
- Class
- Class II
- Product code
- JAI
- Recalls
- 3
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK042146 Robocouch Patient Support SystemAccuray Incorporated · 2004
- Descendant · cites it directly · 6 of its ownK122413 Patient Positioning SystemForte Automation Systems, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK160518 LEONI ORION SystemLeoni Cia Cable System · 2016 · Recalled
- Descendant · 3 generations on · 2 of its ownK221791 ProBeam 360° Proton Therapy SystemVarian Medical Systems, Inc. · 2022
- Descendant · 4 generations on · 1 of its ownK231863 ProBeam 360° Proton Therapy System v2.0 (Multiroom)Varian Medical Systems, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK252815 ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K122413Patient Positioning SystemForte Automation Systems, Inc. · 2012 · cites it directly6descendants
- K160518LEONI ORION SystemLeoni Cia Cable System · 2016 · 2 generations on5descendants
- K221791ProBeam 360° Proton Therapy SystemVarian Medical Systems, Inc. · 2022 · 3 generations on2descendants
- K231863ProBeam 360° Proton Therapy System v2.0 (Multiroom)Varian Medical Systems, Inc. · 2023 · 4 generations on1descendant
- K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042146 | Robocouch Patient Support System | Accuray Incorporated | 2004 | — |
| +1 | K122413 | Patient Positioning System | Forte Automation Systems, Inc. | 2012 | 1 |
| +2 | K160518 | LEONI ORION System | Leoni Cia Cable System | 2016 | 2 |
| +3 | K221791 | ProBeam 360° Proton Therapy System | Varian Medical Systems, Inc. | 2022 | — |
| +4 | K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. | 2023 | — |
| +4 | K252815 | ProBeam 360 Proton Therapy System v3.0 | Varian Medical Systems, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | CyberKnife® System Patient Support Subsystem Named without a submission number | |
| * | — | Elekta Precise Table Named without a submission number |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122413 | Patient Positioning System | 2012 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 27, 2013 | Class II | Z-1155-2013 | Nonconforming Material/Component | A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective. |
| Jul 21, 2009 | Not classified | Z-0853-2011 | Device Design | Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches. |
| Oct 30, 2008 | Not classified | Z-0856-2009 | Process control | Product may not be tensioned properly, potentially causing unexpected rotation or descent. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K122413 (Forte Automation Systems, Inc., 2012) has gone furthest, with 6 descendants 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 RoboCouch Patient Support System is indicated for the support and
positioning of a patient during radiosurgery and radiotherapy procedures and
other medical procedures when precise positioning is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042146: Robocouch Patient Support System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042146
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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