Med Tec Inc
Medical device manufacturer in Orange City, IA.
8510(k) clearances
0PMA approvals
14recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K034054 | Pro Series Couch Software, Model MT-PRO100JAI · Traditional | 02/20/2004SE |
| K031866 | Med-Tec 6 Degree Axis Couch, Model MT-6DACJAI · Traditional | 08/14/2003SE |
| K021360 | Scintillating Fiber Dosimeter (SFD), Model MT-SFD-1000KXK · Traditional | 06/10/2003SE |
| K023293 | Med-Tec Bellyboard, Models MT-BBA-01 & MT-BBA-02IYE · Traditional | 12/23/2002SE |
| K013875 | Med-Tec Compensator Block Cutter SoftwareIXI · Traditional | 09/27/2002SE |
| K001052 | Med-Tec (Medical Intelligence) Bodyfix System, Model Mt-BfxIYE · Traditional | 08/30/2000SE |
| K981992 | Electron Wedge Model MT-EW-1000IXI · Traditional | 12/15/1998SE |
| K982624 | Moldcare Head & Neck Cushion, Model # MT-ACL-14242IYE · Traditional | 10/26/1998SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2243-2020 Class II | Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device…Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. The risk… | 05/12/2020Terminated |
| Z-1837-2019 Class II | CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product…There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or… | 04/15/2019Terminated |
| Z-0671-2018 Class II | Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1…When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal… | 11/08/2017Terminated |
| Z-3083-2017 Class II | CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red…Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and… | 08/10/2017Terminated |
| Z-3082-2017 Class II | CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red…Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and… | 08/10/2017Terminated |
| Z-1992-2016 Class II | Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0…When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be… | 03/31/2016Terminated |
| Z-2763-2015 Class II | CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set…The wrist straps used for positioning the patient are too long | 08/19/2015Terminated |
| Z-0990-2015 Class II | Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist…The product (wool wrist loop) was manufactured 7cm shorter than product specifications. | 12/11/2014Terminated |
| Z-0989-2015 Class II | Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile…The product (wool wrist loop) was manufactured 7cm shorter than product specifications. | 12/11/2014Terminated |
| Z-0396-2011 | CIVCO Posifix Extension, REF MTIL6606, Reusable non-sterile extension for use with the…Under certain conditions, the extensions can become detached from the main body of the couch. | 06/21/2010Terminated |
| Z-0395-2011 | CIVCO Type-S Extension, REF MTIL6605, Reusable non-sterile extension for use with…Under certain conditions, the extensions can become detached from the main body of the couch. | 06/21/2010Terminated |
| Z-0394-2011 | CIVCO Rectangular Extension, REF MTIL6600, Reusable non-sterile extension for use with…Under certain conditions, the extensions can become detached from the main body of the couch. | 06/21/2010Terminated |
| Z-0124-2010 | CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29…Some of the packages contain the incorrect mask style. | 08/31/2009Terminated |
| Z-1721-2009 | Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion.The silkscreened indexing scale was reversed. | 03/06/2009Terminated |