The following data is part of a premarket notification filed by Palodex Group Oy with the FDA for Scanora 3dx.
| Device ID | K130297 |
| 510k Number | K130297 |
| Device Name: | SCANORA 3DX |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | PALODEX GROUP OY NAHKELANTIE 160 Tuusula, FI 04300 |
| Contact | Matti Tulikoura |
| Correspondent | Matti Tulikoura PALODEX GROUP OY NAHKELANTIE 160 Tuusula, FI 04300 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-06 |
| Decision Date | 2013-05-29 |
| Summary: | summary |