3Mensio Medical Imaging BV
Country not established
- Devices
- 2
What 3Mensio Medical Imaging BV makes
3Mensio Medical Imaging BV develops medical imaging software solutions, including the 3VISEON platform for cardiac imaging analysis and the 3VISEON/SURGERY module for intraoperative planning and guidance in cardiac procedures.
These products fall under Class II regulatory classification in the US and are listed via 510(k) clearance with the FDA. The company is based in the United States.
Catalogue
3VISEON Ref K043097
Regimes: 510(k) Registry: 510(k)3VISEON/Surgery Ref K072653
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does 3Mensio Medical Imaging BV have in the registry?
The registry currently lists 2 devices for 3Mensio Medical Imaging BV. Devices recorded under merged duplicate company entries are counted once.
Which registries list 3Mensio Medical Imaging BV's devices?
Among its 2 most recently registered devices, 3Mensio Medical Imaging BV has devices listed in FDA 510(k) (2 devices).
What risk classes do 3Mensio Medical Imaging BV's devices fall under?
Among its 2 most recently registered devices, the classes recorded for 3Mensio Medical Imaging BV's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from 3Mensio Medical Imaging BV in the registry?
The most recently registered devices listed for 3Mensio Medical Imaging BV include 3VISEON and 3VISEON/SURGERY.