# K122413: Patient Positioning System

- Pathway: 510(k) (Traditional)
- Applicant: Forte Automation Systems, Inc.
- Decided: Sep 13, 2012 after 36 days
- Product code: JAI (Couch, Radiation Therapy, Powered)
- Device class: 2
- Regulation: 21 CFR 892.5770
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K042146 (2004). 1 ancestor in all.
6 later devices descend from it; 1 cites 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)
- K042146: Robocouch Patient Support System, Accuray Incorporated (2004) Summary page 1.

## Most influential descendants
- K160518: LEONI ORION System (2016), 5 descendants of its own
- 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

## Recalls of this device
- Sep 5, 2017 · Class II · Z-2537-2018: Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.

## Indications for use
The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.

Source page: https://510kreport.com/device/K122413
Methodology: https://510kreport.com/methodology