# K042146: Robocouch Patient Support System

- Pathway: 510(k) (Traditional)
- Applicant: Accuray Incorporated
- Decided: Sep 17, 2004 after 39 days
- Product code: JAI (Couch, Radiation Therapy, Powered)
- Device class: 2
- Regulation: 21 CFR 892.5770
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 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)
- None. The FDA summary names its predicate without a number.
- (no number) CyberKnife® System Patient Support Subsystem: named in the summary without a submission number
- (no number) Elekta Precise Table: named in the summary without a submission number

## Most influential descendants
- K122413: Patient Positioning System (2012), 6 descendants of its own
- 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

## Recalls of this device
- Mar 27, 2013 · Class II · Z-1155-2013: 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: Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches.
- Oct 30, 2008 · Not classified · Z-0856-2009: Product may not be tensioned properly, potentially causing unexpected rotation or descent.

## Indications for use
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.

Source page: https://510kreport.com/device/K042146
Methodology: https://510kreport.com/methodology