The following data is part of a premarket notification filed by Orion Corporation Soredex with the FDA for Digora For Windows 2.0.
| Device ID | K983267 |
| 510k Number | K983267 |
| Device Name: | DIGORA FOR WINDOWS 2.0 |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | ORION CORPORATION SOREDEX NILSIANKATU 10-14 Helsinki, FI Fin-00510 |
| Contact | Kai Laner |
| Correspondent | Kai Laner ORION CORPORATION SOREDEX NILSIANKATU 10-14 Helsinki, FI Fin-00510 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-17 |
| Decision Date | 1998-12-30 |
| Summary: | summary |