The following data is part of a premarket notification filed by Planmed Oy with the FDA for Planmed Verity.
| Device ID | K213278 |
| 510k Number | K213278 |
| Device Name: | Planmed Verity |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | Planmed Oy Sorvaajankatu 7 Helsinki, FI 00880 |
| Contact | Niina Vuorikallas |
| Correspondent | Niina Vuorikallas Planmed Oy Sorvaajankatu 7 Helsinki, FI 00880 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-01 |
| Decision Date | 2022-04-28 |