510(k) · Cleared
ClearedEve Patient Positioner System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leo Cancer Care · JAI Couch, Radiation Therapy, Powered
Cleared on May 7, 2024 as substantially equivalent to K160518 (Leoni Cia Cable System, 2016) after a 340-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- May 7, 2024
- Review
- 340 days
- Class
- Class II
- Product code
- JAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042146 (2004). No later device cites it as a predicate yet.
- Root · 3 generations backK042146 Robocouch Patient Support SystemAccuray Incorporated · 2004 · Recalled
- 2 generations backK122413 Patient Positioning SystemForte Automation Systems, Inc. · 2012 · Recalled
- 1 generation backK160518 LEONI ORION SystemLeoni Cia Cable System · 2016 · Recalled
- This deviceK231612 Eve Patient Positioner SystemLeo Cancer Care · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042146 | Robocouch Patient Support System | Accuray Incorporated | 2004 | 3 |
| −2 | K122413 | Patient Positioning System | Forte Automation Systems, Inc. | 2012 | 1 |
| −1 | K160518 | LEONI ORION System | Leoni Cia Cable System | 2016 | 2 |
| 0 (this device) | K231612 | Eve Patient Positioner System | Leo Cancer Care | 2024 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K160518 | LEONI ORION SystemSummary page 4…rip�on: Couch, radia�on therapy, powered Product Code: JAI III. PREDICATE Predicate device: LEONI Orion System K160518 IV. INTENDED USE The Leo Cancer Care Patient Positioning Subsystem is indicated for precise positioning of hum… | 2016 |
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.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- 3 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K160518.
How does its category compare?
All JAI devicesJAI Couch, Radiation Therapy, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Leo Cancer Care Patient Positioning Subsystem is indicated for precise positioning of human patients to facilitate
delivery of external beam radiation when integrated with a separate beam therapy treatment delivery device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231612: Eve Patient Positioner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231612
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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