Med-Tec, Inc. D/B/A Civco Medical Solutions
United StatesFDA applicant, unverified
- Devices
- 5
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Med-Tec, Inc. D/B/A Civco Medical Solutions makes
Med-Tec, Inc. (Civco Medical Solutions) manufactures radiation therapy treatment couches with integrated software for patient positioning and imaging alignment, designed to enhance precision in radiotherapy delivery.
The company’s products are classified as Class II medical devices in the U.S. and are listed under the FDA’s 510(k) pathway, reflecting compliance with regulatory requirements for moderate-risk devices. The manufacturer operates from the United States.
Catalogue
Bellyboard, Sbrt Accessories Ref K121545
Regimes: 510(k) Registry: 510(k)Protura Couch Software Ref K122201
Regimes: 510(k) Registry: 510(k)Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask Ref K182079
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Protura Couch Software Ref K132084
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Med-Tec, Inc. D/B/A Civco Medical Solutions, initiated on 2008-02-28. By recorded status: 2 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 28 Feb 2008 Z-1613-2008 Unclassified (pre-2012) Terminated Mislabeled: Fiducial markers were incorrectly labeled. They are marked (2mm spheres) Bone gold markers, but contain (0.9x3mm cylindrical) Soft tissue gold markers.
- 28 Feb 2008 Z-1614-2008 Unclassified (pre-2012) Terminated Mislabeled: Fiducial markers were incorrectly labeled. They are marked (0.9x3mm cylindrical) Soft tissue gold markers, but contain (2mm spheres) Bone gold markers.
Frequently asked questions
How many devices does Med-Tec, Inc. D/B/A Civco Medical Solutions have in the registry?
The registry currently lists 5 devices for Med-Tec, Inc. D/B/A Civco Medical Solutions. Devices recorded under merged duplicate company entries are counted once.
Which registries list Med-Tec, Inc. D/B/A Civco Medical Solutions's devices?
Among its 5 most recently registered devices, Med-Tec, Inc. D/B/A Civco Medical Solutions has devices listed in FDA 510(k) (5 devices).
What risk classes do Med-Tec, Inc. D/B/A Civco Medical Solutions's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Med-Tec, Inc. D/B/A Civco Medical Solutions's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Med-Tec, Inc. D/B/A Civco Medical Solutions?
FDA recall records list 2 recalls initiated by Med-Tec, Inc. D/B/A Civco Medical Solutions, the most recent initiated on 28 Feb 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Med-Tec, Inc. D/B/A Civco Medical Solutions in the registry?
The most recently registered devices listed for Med-Tec, Inc. D/B/A Civco Medical Solutions include BELLYBOARD, SBRT ACCESSORIES, PROTURA COUCH SOFTWARE, Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask and Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement.