Company ยท US
Med Tec Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2004. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
14recalls (0 in 12 months)
9recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 20, 2004 | K034054 | PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 Med-Tec,Inc. | JAI |
| Aug 14, 2003 | K031866 | MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC Med-Tec,Inc. | JAI |
| Jun 10, 2003 | K021360 | SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 Med-Tec,Inc. | KXK |
| Dec 23, 2002 | K023293 | MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 Med-Tec,Inc. | IYE |
| Sep 27, 2002 | K013875 | MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE Med-Tec,Inc. | IXI |
| Aug 30, 2000 | K001052 | MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX Med-Tec,Inc. | IYE |
| Dec 15, 1998 | K981992 | ELECTRON WEDGE MODEL MT-EW-1000 Med-Tec,Inc. | IXI |
| Oct 26, 1998 | K982624 | MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 Med-Tec,Inc. | IYE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2020 | Med Tec Inc Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning. Terminated |
IYE | K933227 |
| Apr 15, 2019 | Med Tec Inc 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. Terminated |
IYE | K182079 |
| 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 | K132084 |
| Aug 10, 2017 | Med Tec Inc 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-2 Terminated |
KXH | None listed |
| Aug 10, 2017 | Med Tec Inc 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) P Terminated |
KXH | 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 | K132084 |
| Sep 14, 2015 | Med Tec Inc 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 radiother Terminated |
FMQ | None listed |
| Jan 15, 2015 | Med Tec Inc 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 Terminated |
FMQ | None listed |
| Jan 15, 2015 | Med Tec Inc 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 c Terminated |
FMQ | None listed |
| Nov 16, 2010 | Med Tec Inc 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 positi Terminated |
IXQ | K973842 |
| Nov 16, 2010 | Med Tec Inc 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 Terminated |
IXQ | K973842 |
| Nov 16, 2010 | Med Tec Inc 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 positio Terminated |
IXQ | K973842 |
| Nov 6, 2009 | Med Tec Inc 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, Terminated |
IYE | K933227 |
| Aug 20, 2009 | Med Tec Inc Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion. Terminated |
IXQ | K973842 |