The following data is part of a premarket notification filed by Soredex Palodex Group Oy with the FDA for Scanora 3d.
| Device ID | K073350 |
| 510k Number | K073350 |
| Device Name: | SCANORA 3D |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | SOREDEX PALODEX GROUP OY NAHKELANTIE 160 Tuusula, FI Fin-04300 |
| Contact | Jouni Onnela |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-11-29 |
| Decision Date | 2007-12-19 |
| Summary: | summary |