Cardionxt, Inc.
Country not established
- Devices
- 6
What Cardionxt, Inc. makes
Cardionxt, Inc. manufactures the iMap 3D Mapping & Navigation System, a device designed for electroanatomical mapping and intracardiac navigation during cardiac procedures, enabling precise visualization of cardiac structures and real-time guidance for interventions.
The iMap System is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 117364041
Frequently asked questions
How many devices does Cardionxt, Inc. have in the registry?
The registry currently lists 6 devices for Cardionxt, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardionxt, Inc.'s devices?
Among its 6 most recently registered devices, Cardionxt, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Cardionxt, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Cardionxt, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardionxt, Inc. in the registry?
The most recently registered devices listed for Cardionxt, Inc. include Axis Patient Patches 821010, Multilink CS Catheter 821003, iMap 3D Mapping and Navigation System 820000 and iMap Computer Cart 825500.