510(k) K132084 ยท JAI Couch, Radiation Therapy, Powered
PROTURA COUCH SOFTWARE
| Applicant | Med-Tec, Inc. D/B/A Civco Medical Solutions, Orange City IA, US |
| Decision | Substantially Equivalent, Sep 26, 2013 |
| Received | Jul 5, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132084
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2017 | Med Tec Inc Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, Terminated |
JAI | None listed |
| Mar 31, 2016 | Med Tec Inc Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041 Terminated |
JAI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.