# K122201: Protura Couch Software

- Pathway: 510(k) (Traditional)
- Applicant: Med-Tec, Inc. D/B/A Civco Medical Solutions
- Decided: Aug 30, 2012 after 36 days
- Product code: JAI (Couch, Radiation Therapy, Powered)
- Device class: 2
- Regulation: 21 CFR 892.5770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K034054 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034054: Pro Series Couch Software, Model MT-PRO100, Med-Tec,Inc. (2004) Summary page 1.

## Indications for use
The Protura Couch Software is intended to interface between a record and verify system, linear accelerator (Linac) software, 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/K122201
Methodology: https://510kreport.com/methodology