# K160518: LEONI ORION System

- Pathway: 510(k) (Traditional)
- Applicant: Leoni Cia Cable System
- Decided: Jul 14, 2016 after 141 days
- Product code: JAI (Couch, Radiation Therapy, Powered)
- Device class: 2
- Regulation: 21 CFR 892.5770
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K042146 (2004). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122413: Patient Positioning System, Forte Automation Systems, Inc. (2012) Summary page 4.

## Most influential descendants
- K221791: ProBeam 360°  Proton Therapy System (2022), 2 descendants of its own
- K231863: ProBeam 360° Proton Therapy System v2.0 (Multiroom) (2023), 1 descendant of its own
- K252815: ProBeam 360 Proton Therapy System v3.0 (2026), 0 descendants of its own
- K231612: Eve Patient Positioner System (2024), 0 descendants of its own
- K182683: Z-Robot Patient Positioning System (2019), 0 descendants of its own

## Recalls of this device
- Oct 6, 2023 · Class II · Z-0398-2024: 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 unfo
- Oct 6, 2023 · Class II · Z-0399-2024: 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 unfo

## Indications for use
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.

Source page: https://510kreport.com/device/K160518
Methodology: https://510kreport.com/methodology