PROTURA COUCH SOFTWARE— 510(k) K132084
Substantially EquivalentMed-Tec, Inc. D/B/A Civco Medical Solutions
FDA 510(k) clearance K132084 for PROTURA COUCH SOFTWARE, Substantially Equivalent on 2013-09-26. Applicant: Med-Tec, Inc. D/B/A Civco Medical Solutions. Device class: 2.
Clearance details
- Applicant
- Med-Tec, Inc. D/B/A Civco Medical Solutions
- Product code
- Code JAI
- Device class
- Class 2
- Regulation
- 21 CFR 892.5770
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orange City, IA, US
Recent devices under product code JAI
view allMore clearances from Med-Tec, Inc. D/B/A Civco Medical Solutions
view allRecalls naming K132084
K-number listed on FDA's recall record- Z-0671-2018 — 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, MT6XSM1.7.3-1, MT6XSM1.7.3-3. The Protura Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, and/or image guidance systems and the Protura Couch. The system is intended to support a treatment table and add pitch and roll to normal X, Y, Z and yaw motions to provide 6-degree axis movement. The product includes an interface between the treatment planning system and the treatment table to direct the table motion based on coordinates supplied. These products connect or support a treatment table by use of various mounting plates.
- Z-1992-2016 — 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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132084.
Data sourced from openFDA. This site is unofficial and independent of the FDA.