Data / Medical devices / United States / Medtec LLC
Medtec LLC: FDA-registered device maker in Orange City, IA, United States, 25 510(k) clearances
Medtec LLC is registered with the FDA (registration 1932738) in Orange City, IA, United States. It lists 11 device types. The FDA files 25 510(k) clearances under its listings, the newest dated August 22, 2023. 11 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1932738
- FEI number
- 1000143606
- Address
- 1401 8TH ST. S.E., Orange City, IA, United States, 51041
- Owner or operator
- Medtec LLC (9033077)
- Roles
- Manufacturer, Specification developer
- First device listed
- January 28, 1994
- Registered through
- 2026
- Brand names listed
- ,, AccuForm Cushion, AccuTatt; Accu-Tatt; ISO Mark; Opti-Tatt, Bellyboard, BioXmark, Body Pro-Lok Respiratory Plate with Cushion, Body Pro-Lok Respiratory Belt, BrachyGel Vaginal Hydrogel Packing System, Breast Board and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Couch, Radiation Therapy, Powered | JAI | 2 | Manufacturer | accessdata.fda.gov |
| Holder, Head, Radiographic | IWY | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Manufacturer | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Manufacturer | accessdata.fda.gov |
| Phantom, Anthropomorphic, Radiographic | IXG | 1 | Manufacturer | accessdata.fda.gov |
| Phase-Changing Fiducial Marker For Radiation Therapy | QUV | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Manufacturer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Manufacturer | accessdata.fda.gov |
| Table, Radiographic, Stationary Top | IXQ | 2 | Manufacturer | accessdata.fda.gov |
| Vaginal Hydrogel Packing System | QXR | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 22, 2023 | DEN220052 | BrachyGel Vaginal Hydrogel Packing System | QXR | Unknown | Brachyfoam, Inc. D/B/A Advaray | accessdata.fda.gov |
| December 23, 2022 | DEN220017 | BioXmark | QUV | Unknown | Nanovi A/S | accessdata.fda.gov |
| May 20, 2021 | K211001 | C-Qual M Breastboard; Monarch Overhead Arm Positioner | IYE | Substantially Equivalent | Medtec, Inc. Dba Civco Medical Solutions and Civco | accessdata.fda.gov |
| September 7, 2018 | K182079 | Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask | IYE | Substantially Equivalent | Medtec Inc. Dba Civco Medical Solutions | accessdata.fda.gov |
| June 29, 2018 | K180021 | Proton Positioing and Immobilization Devices | IYE | Substantially Equivalent | Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap | accessdata.fda.gov |
| May 25, 2016 | K153026 | Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement | IYE | Substantially Equivalent | Medtec, Inc. D/B/A Civco Medical Solutions | accessdata.fda.gov |
| March 4, 2014 | K132908 | TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT | IYE | Substantially Equivalent | Medtec, Inc. | accessdata.fda.gov |
| September 26, 2013 | K132084 | PROTURA COUCH SOFTWARE | JAI | Substantially Equivalent | Med-Tec, Inc. D/B/A Civco Medical Solutions | accessdata.fda.gov |
| June 20, 2012 | K120916 | QFIX RADIOTHERAPY CHAIR | JAI | Substantially Equivalent | Wfr/Aquaplast Corp. | accessdata.fda.gov |
| June 8, 2012 | K121545 | BELLYBOARD, SBRT ACCESSORIES | LNH | Substantially Equivalent | Medtec Inc. Dba Civco Medical Solutions | accessdata.fda.gov |
| June 28, 2011 | K111340 | HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM | LNH | Substantially Equivalent | Medtec, Inc. | accessdata.fda.gov |
| May 14, 2010 | K093738 | MRI PATIENT POSITIONING DEVICES | LNH | Substantially Equivalent | Medtec, Inc. | accessdata.fda.gov |
| June 4, 2008 | K080072 | MRI PATIENT POSITIONING DEVICES | IYE | Substantially Equivalent | CIVCO Medical Instruments Co., Inc. | accessdata.fda.gov |
| September 11, 2007 | K071614 | FIDUCIAL MARKERS | IYE | Substantially Equivalent | Civco | accessdata.fda.gov |
| March 31, 2006 | K060737 | SINMED POSITIONING DEVICES | IYE | Substantially Equivalent | Sinmed BV | accessdata.fda.gov |
| August 14, 2003 | K031866 | MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC | JAI | Substantially Equivalent | Med-Tec,Inc. | accessdata.fda.gov |
| December 23, 2002 | K023293 | MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 | IYE | Substantially Equivalent | Med-Tec,Inc. | accessdata.fda.gov |
| October 26, 1998 | K982624 | MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 | IYE | Substantially Equivalent | Med-Tec,Inc. | accessdata.fda.gov |
| March 10, 1998 | K974703 | CARBON FIBER BREAST BOARD | IYE | Substantially Equivalent | Medtec, Inc. | accessdata.fda.gov |
| December 5, 1997 | K973842 | CARBON FIBER CONFORMAL COUCH TOP | IXQ | Substantially Equivalent | Medtec, Inc. | accessdata.fda.gov |
| July 6, 1995 | K951808 | MED-TEC REDI-FOAM | IYE | Substantially Equivalent | Medtec, Inc. | accessdata.fda.gov |
| May 30, 1995 | K950866 | HIP FIXATION SYSTEM | IYE | Substantially Equivalent | Medtec, Inc. | accessdata.fda.gov |
| July 18, 1994 | K935411 | MED-TEC, INC. BREAST BOARD, MT-250 | IYE | Substantially Equivalent | Medtec, Inc. | accessdata.fda.gov |
| July 18, 1994 | K935300 | VAC-LOK IMMOBILIZATION SYSTEM | IYE | Substantially Equivalent | Medtec, Inc. | accessdata.fda.gov |
| July 18, 1994 | K933227 | UNI-FRAME HEAD IMMOBILIZATION SYSTEM | IYE | Substantially Equivalent | Medtec, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 12, 2020 | 85654 | Class II | Terminated | Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning. | Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. The risk associated with the disengagement of the extension could be a patient fall if the patient is not supported by clinical staff. | accessdata.fda.gov |
| April 15, 2019 | 82641 | Class II | Terminated | CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanent | There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment. | accessdata.fda.gov |
| November 8, 2017 | 79182 | Class II | Terminated | 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, MT6X | 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 pedestal location and buffers the pedestal movement history. | accessdata.fda.gov |
| August 10, 2017 | 77874 | Class II | Terminated | CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm Support, Set (PN: 106020) (c) PSR2-CR-DLR-2P Posirest-2 (PN: 106521) (d) PB2-BLR Posiboard-2 (PN: 10 | Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm. | accessdata.fda.gov |
| March 31, 2016 | 73692 | Class II | Terminated | 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 | When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters. | accessdata.fda.gov |
| August 19, 2015 | 71935 | Class II | Terminated | CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and trea | The wrist straps used for positioning the patient are too long | accessdata.fda.gov |
| December 11, 2014 | 69997 | Class II | Terminated | Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, The devise is intended to pull patients shoulders down for clearance when treating | The product (wool wrist loop) was manufactured 7cm shorter than product specifications. | accessdata.fda.gov |
| June 21, 2010 | 55999 | Not yet classified | Terminated | CIVCO Rectangular Extension, REF MTIL6600, Reusable non-sterile extension for use with Universal Couchtop. The firm name on the label is CIVCO, Orange City, IA. For use to support and aid in positioning a patient during | Under certain conditions, the extensions can become detached from the main body of the couch. | accessdata.fda.gov |
| August 31, 2009 | 53142 | Not yet classified | Terminated | CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29 thermoplastic (3.2 mm), Ref. MTAPSID2932, disposable frame mask, 5 per box. The firm name on the label is CIVCO, Orange City, IA. Inte | Some of the packages contain the incorrect mask style. | accessdata.fda.gov |
| March 6, 2009 | 51317 | Not yet classified | Terminated | Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion. | The silkscreened indexing scale was reversed. | accessdata.fda.gov |
| February 28, 2008 | 46905 | Not yet classified | Terminated | Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-805, CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041. | Mislabeled: Fiducial markers were incorrectly labeled. They are marked (2mm spheres) Bone gold markers, but contain (0.9x3mm cylindrical) Soft tissue gold markers. | accessdata.fda.gov |
Compare with other makers
- All makers of Accelerator, Linear, Medical
- All makers of Couch, Radiation Therapy, Powered
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of Marker, Skin
- All makers of Vaginal Hydrogel Packing System
- All makers of Phantom, Anthropomorphic, Radiographic
Updated August 22, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.