Orion Corporation Soredex
FinlandFDA 510(k) applicant, unverified
- Devices
- 4
What Orion Corporation Soredex makes
Orion Corporation Soredex manufactures intraoral and panoramic dental X-ray imaging systems, including software platforms like DIGORA for Windows and standalone versions, as well as cephalometric and panoramic imaging units such as the ORALIX PAN DC III and CRANEX TOME.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Digora For Windows 2.0 Ref K983267
510(k) 510(k)Digora Ref K934949
510(k) 510(k)Oralix Pan Dc Iii Ceph Or Panoramic Mode Only Ref K880982
510(k) 510(k)Cranex Tome Ceph, Or Cranex Tome Ref K974877
510(k) 510(k)
Frequently asked questions
How many devices does Orion Corporation Soredex have in the registry?
The registry currently lists 4 devices for Orion Corporation Soredex. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orion Corporation Soredex's devices?
Among its 4 most recently registered devices, Orion Corporation Soredex has devices listed in FDA 510(k) (4 devices).
What risk classes do Orion Corporation Soredex's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Orion Corporation Soredex's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orion Corporation Soredex in the registry?
The most recently registered devices listed for Orion Corporation Soredex include DIGORA FOR WINDOWS 2.0, DIGORA, ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY and CRANEX TOME CEPH, OR CRANEX TOME.