# K132084: Protura Couch Software

- Pathway: 510(k) (Traditional)
- Applicant: Med-Tec, Inc. D/B/A Civco Medical Solutions
- Decided: Sep 26, 2013 after 83 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K1221: Protura Couch Software. Number could not be read Summary page 1.

## Recalls of this device
- Nov 8, 2017 · Class II · Z-0671-2018: When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal coordinates, moving the pedestal could cause the Protura software to not update with the ped
- Mar 31, 2016 · Class II · Z-1992-2016: When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.

## Indications for use
The Protura Couch Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, Linac safeguard systems, and/or image guidance systems and the Protura Couch. The Protura Couch Software is also capable of operating the Protura Couch (6 Degree Axis Couch).

Source page: https://510kreport.com/device/K132084
Methodology: https://510kreport.com/methodology