Medtec LLC
Orange City, IA, US
MEDTEC LLC appears in FDA device records in Orange City, IA. FDA records list 49 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 16 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Medtec LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Med Tec Inc dba CIVCO Medical Solutionsrecall
- Med-Tec,Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 49 510(k) clearances for Medtec LLC between 1993 and 2014. The busiest year on record is 1994, with 15. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 2 |
| 1994 | 15 |
| 1995 | 15 |
| 1996 | 3 |
| 1997 | 1 |
| 1998 | 4 |
| 2000 | 1 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K132908 | TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT | IYE | Substantially Equivalent | |
| K111340 | HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM | LNH | Substantially Equivalent | |
| K093738 | MRI PATIENT POSITIONING DEVICES | LNH | Substantially Equivalent | |
| K034054 | PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 | JAI | Substantially Equivalent | |
| K031866 | MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC | JAI | Substantially Equivalent | |
| K021360 | SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 | KXK | Substantially Equivalent | |
| K023293 | MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 | IYE | Substantially Equivalent | |
| K013875 | MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE | IXI | Substantially Equivalent | |
| K001052 | MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX | IYE | Substantially Equivalent | |
| K981992 | ELECTRON WEDGE MODEL MT-EW-1000 | IXI | Substantially Equivalent | |
| K982624 | MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 | IYE | Substantially Equivalent | |
| K974703 | CARBON FIBER BREAST BOARD | IYE | Substantially Equivalent | |
| K974700 | MATRIX MT-MX3 | IYE | Substantially Equivalent | |
| K973842 | CARBON FIBER CONFORMAL COUCH TOP | IXQ | Substantially Equivalent | |
| K962622 | INTRA-ORAL THERMOPLASTIC SHIELD | KPY | Substantially Equivalent | |
| K955236 | GREEN TEC-2100 | IWE | Substantially Equivalent | |
| K954705 | ACRYSTEEL BLOCKING TRAY | IYE | Substantially Equivalent | |
| K954456 | THERMOPLASTIC SHIELD | KPY | Substantially Equivalent | |
| K954225 | MED-TEC HAND GRIP | IXQ | Substantially Equivalent | |
| K951753 | MEDTEC AUTOBLOT 2000 | JQW | Substantially Equivalent | |
| K952729 | PAINTED WEDGE & ROD BREAST BOARD | IYE | Substantially Equivalent | |
| K950293 | TEC-2110 GREEN LASER MODEL MT-HNG | IWE | Substantially Equivalent | |
| K952189 | MED-TEC REDISET | IYE | Substantially Equivalent | |
| K950075 | MED-TEC TRAY ADAPTER | IYE | Substantially Equivalent | |
| K951947 | MED-TEC RADIO THERAPY TREATMENT CHAIR | IYE | Substantially Equivalent | |
| K951679 | MED-TEC TESTICULAR SEPARATOR | IYE | Substantially Equivalent | |
| K951808 | MED-TEC REDI-FOAM | IYE | Substantially Equivalent | |
| K951717 | MED-TEC KNEE CRUTCH | IYE | Substantially Equivalent | |
| K945515 | COATED TUNGSTEN EYESHIELD | IWS | Substantially Equivalent | |
| K950866 | HIP FIXATION SYSTEM | IYE | Substantially Equivalent | |
| K951601 | MED-TEC STRING RETICLE TRAY | IWE | Substantially Equivalent | |
| K950068 | CARBON FIBER COUCH INSERT | KXJ | Substantially Equivalent | |
| K943343 | FIELD ABUTMENT WEDGE | IXI | Substantially Equivalent | |
| K943011 | TUNGSTEN EYESHIELD | IWS | Substantially Equivalent | |
| K943802 | HP BACK POINTER SYSTEM | IWE | Substantially Equivalent | |
| K943199 | MOTORIZED DEPTH DOSE APPARATUS | IYE | Substantially Equivalent | |
| K944315 | BLOCKING TRAY | IYE | Substantially Equivalent | |
| K941600 | MT-300 CASSETTE HOLDER | IXA | Substantially Equivalent | |
| K942282 | MED-TEC BREAST SUPPORT SYSTEM | IYE | Substantially Equivalent | |
| K941719 | 360 DEG. ROTATING 1/2 BEAM BLOCK | IXI | Substantially Equivalent | |
| K941169 | TEC 2101 (MODEL MT-HPLGD) | IWE | Substantially Equivalent | |
| K935412 | MED-TEC, INC. BREAST BOARD, MT-200 | IYE | Substantially Equivalent | |
| K935411 | MED-TEC, INC. BREAST BOARD, MT-250 | IYE | Substantially Equivalent | |
| K935300 | VAC-LOK IMMOBILIZATION SYSTEM | IYE | Substantially Equivalent | |
| K933227 | UNI-FRAME HEAD IMMOBILIZATION SYSTEM | IYE | Substantially Equivalent | |
| K935021 | HANDI-FOAM | IYE | Substantially Equivalent | |
| K935760 | TEC 2100 (MODEL MT-LPLGD) | IWE | Substantially Equivalent | |
| K935209 | INSTA-FLO | JAD | Substantially Equivalent | |
| K934519 | RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM | IWE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1932738 | 1000143606 | MEDTEC LLC | 1401 8TH ST. S.E., Orange City, IA 51041 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- IXIBlock, Beam-Shaping, Radiation Therapy
- IXACassette, Radiographic Film
- JAICouch, Radiation Therapy, Powered
- IWYHolder, Head, Radiographic
- LHOInstrument, Quality-Assurance, Radiologic
- FZZMarker, Skin
- IWEMonitor, Patient Position, Light-Beam
- IXGPhantom, Anthropomorphic, Radiographic
- QUVPhase-Changing Fiducial Marker For Radiation Therapy
- IWSShield, Eye, Radiological
- KPYShield, Protective, Personnel
- KXKSource, Brachytherapy, Radionuclide
- JQWStation, Pipetting And Diluting, For Clinical Use
- LNHSystem, Nuclear Magnetic Resonance Imaging
- JADSystem, Therapeutic, X-Ray
- IXQTable, Radiographic, Stationary Top
- KXJTable, Radiologic
- QXRVaginal Hydrogel Packing System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2243-2020 | 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. | Class II | Terminated | |
| Z-1837-2019 | 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 permanently attached to the baseplate and the locking level allows the bowl to be tilted up to approximately 10 in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can immobilize the patient to under 1 millimeter. The provider can correct the patient position for simulation and treatments by tilting the device. | There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment. | Class II | Terminated | |
| 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. | 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. | Class II | Terminated | |
| Z-3083-2017 | CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment. | 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. | Class II | Terminated | |
| Z-3082-2017 | 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: 109030) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.. | 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. | Class II | Terminated | |
| 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 | When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters. | Class II | Terminated | |
| Z-2763-2015 | 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 treatment sessions where opposed lateral fields are used in the neck area. | The wrist straps used for positioning the patient are too long | Class II | Terminated | |
| Z-0990-2015 | Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-sterile re-usable wool wrist strap, REF: 20SR03, Rx The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck. | The product (wool wrist loop) was manufactured 7cm shorter than product specifications. | Class II | Terminated | |
| Z-0989-2015 | 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 lateral fields to the neck. | The product (wool wrist loop) was manufactured 7cm shorter than product specifications. | Class II | Terminated | |
| Z-0396-2011 | CIVCO Posifix Extension, REF MTIL6606, Reusable non-sterile extension for use with the Universal Couchtop. The firm name on the label is CIVCO, Orange City, IA. For use to support and aid in positioning a patient during radiologic and other medical procedures. | Under certain conditions, the extensions can become detached from the main body of the couch. | Terminated | ||
| Z-0395-2011 | CIVCO Type-S Extension, REF MTIL6605, 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 radiologic and other medical procedures. | Under certain conditions, the extensions can become detached from the main body of the couch. | Terminated | ||
| Z-0394-2011 | 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 radiologic and other medical procedures. | Under certain conditions, the extensions can become detached from the main body of the couch. | Terminated | ||
| Z-0124-2010 | 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. Intended to be used for patient fixation. | Some of the packages contain the incorrect mask style. | Terminated | ||
| 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. | Terminated | ||
| Z-1614-2008 | Fiducial Markers (0.9 x 3 mm) Soft tissue gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-809, CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041. | Mislabeled: Fiducial markers were incorrectly labeled. They are marked (0.9x3mm cylindrical) Soft tissue gold markers, but contain (2mm spheres) Bone gold markers. | Terminated | ||
| Z-1613-2008 | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain