Civco
Country not established
- Devices
- 2
What Civco makes
Civco manufactures needle guidance systems for medical imaging procedures, including the ETRAX Needle System, ETRAX Variable Angle Needle Guidance System, and the VIRTUTRAX Universal Tracker, which assist in precise needle placement. The company also produces fiducial markers used as reference points in imaging and navigation during interventions.
These devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. Civco’s products are listed in the FDA’s 510(k) registry, and the company operates from the United States.
Catalogue
Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal Tracker Ref K092619
Regimes: 510(k) Registry: 510(k)Fiducial Markers Ref K071614
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Civco have in the registry?
The registry currently lists 2 devices for Civco. Devices recorded under merged duplicate company entries are counted once.
Which registries list Civco's devices?
Among its 2 most recently registered devices, Civco has devices listed in FDA 510(k) (2 devices).
What risk classes do Civco's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Civco's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Civco in the registry?
The most recently registered devices listed for Civco include ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER and FIDUCIAL MARKERS.