510(k) · Cleared
Recalled · Class II · 2023LEONI ORION System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leoni Cia Cable System · JAI Couch, Radiation Therapy, Powered
Cleared on Jul 14, 2016 as substantially equivalent to K122413 (Forte Automation Systems, Inc., 2012) after a 141-day review. Its family tree reaches back 2 generations to 2004. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 14, 2016
- Review
- 141 days
- Class
- Class II
- Product code
- JAI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042146 (2004). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK042146 Robocouch Patient Support SystemAccuray Incorporated · 2004 · Recalled
- 1 generation backK122413 Patient Positioning SystemForte Automation Systems, Inc. · 2012 · Recalled
- This deviceK160518 LEONI ORION SystemLeoni Cia Cable System · 2016
- Descendant · cites it directly · 2 of its ownK221791 ProBeam 360° Proton Therapy SystemVarian Medical Systems, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK231863 ProBeam 360° Proton Therapy System v2.0 (Multiroom)Varian Medical Systems, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK252815 ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK231612 Eve Patient Positioner SystemLeo Cancer Care · 2024
- Descendant · cites it directly · 0 of its ownK182683 Z-Robot Patient Positioning SystemChinan Biomedical Technology, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K221791ProBeam 360° Proton Therapy SystemVarian Medical Systems, Inc. · 2022 · cites it directly2descendants
- K231863ProBeam 360° Proton Therapy System v2.0 (Multiroom)Varian Medical Systems, Inc. · 2023 · 2 generations on1descendant
- K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc. · 2026 · 2 generations on0descendants
- K231612Eve Patient Positioner SystemLeo Cancer Care · 2024 · cites it directly0descendants
- K182683Z-Robot Patient Positioning SystemChinan Biomedical Technology, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042146 | Robocouch Patient Support System | Accuray Incorporated | 2004 | 3 |
| −1 | K122413 | Patient Positioning System | Forte Automation Systems, Inc. | 2012 | 1 |
| 0 (this device) | K160518 | LEONI ORION System | Leoni Cia Cable System | 2016 | — |
| +1 | K221791 | ProBeam 360° Proton Therapy System | Varian Medical Systems, Inc. | 2022 | — |
| +2 | K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) | Varian Medical Systems, Inc. | 2023 | — |
| +2 | K252815 | ProBeam 360 Proton Therapy System v3.0 | Varian Medical Systems, Inc. | 2026 | — |
| +1 | K231612 | Eve Patient Positioner System | Leo Cancer Care | 2024 | — |
| +1 | K182683 | Z-Robot Patient Positioning System | Chinan Biomedical Technology, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K122413 | Patient Positioning SystemSummary page 4…CFR 892.5770) Product Code: JAI Substantial Equivalence Patient Positioning System by Forte Automation Systems (K122413) Device Description The LEONI ORION System is an electro-mechanical robotic arm capable of… | 2012 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 6, 2023 | Class II | Z-0398-2024 | Software design | Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen interruption signal of motion… |
| Oct 6, 2023 | Class II | Z-0399-2024 | Software design | Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen interruption signal of motion… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K221791 (Varian Medical Systems, Inc., 2022) has gone furthest, with 2 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. 2016, 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 LEONI Orion System in an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. It is designed for positioning a patient with a high degree of accuracy and repeatability.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160518 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160518: LEONI ORION System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160518
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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