Owandy
Country not established
- Devices
- 7
What Owandy makes
Owandy manufactures digital X-ray sensors and imaging systems, including wireless and touch-enabled devices for cephalometric and intraoral radiography, as well as high-definition video recording equipment for medical applications.
The company’s products are classified as Class II medical devices and are listed under FDA’s 510(k) clearance process. Owandy is based in the United States.
Catalogue
Imax Ceph Digital X-Ray Sensor Ref K062403
510(k) 510(k)Universal-X (Usa) Or /Krystal-X (Europe) Ref K053172
510(k) 510(k)Visteo Ref K093105
510(k) 510(k)I-Max Touch Ref K083057
510(k) 510(k)Opteo, Videograph Hd Ref K133271
510(k) 510(k)I-Max Touch 3D Ref K130443
510(k) 510(k)Krystal-X Wifi Ref K070505
510(k) 510(k)
Frequently asked questions
How many devices does Owandy have in the registry?
The registry currently lists 7 devices for Owandy. Devices recorded under merged duplicate company entries are counted once.
Which registries list Owandy's devices?
Among its 7 most recently registered devices, Owandy has devices listed in FDA 510(k) (7 devices).
What risk classes do Owandy's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Owandy's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Owandy in the registry?
The most recently registered devices listed for Owandy include IMAX CEPH DIGITAL X-RAY SENSOR, UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE), VISTEO and I-MAX TOUCH.