The following data is part of a premarket notification filed by Soredex Palodex Group Oy with the FDA for Digora Pct/digipod.
| Device ID | K070304 |
| 510k Number | K070304 |
| Device Name: | DIGORA PCT/DIGIPOD |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | SOREDEX PALODEX GROUP OY NAHKELANTIE 160 Tuusula, FI Fin-04300 |
| Contact | Kai Laner |
| Correspondent | Kai Laner SOREDEX PALODEX GROUP OY NAHKELANTIE 160 Tuusula, FI Fin-04300 |
| Product Code | MUH |
| Subsequent Product Code | EHD |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-31 |
| Decision Date | 2007-03-27 |
| Summary: | summary |