The following data is part of a premarket notification filed by Planmed Oy with the FDA for Planmed Verity.
| Device ID | K121418 |
| 510k Number | K121418 |
| Device Name: | PLANMED VERITY |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | PLANMED OY Sorvaajankatu 7 Helsinki, FI 00880 |
| Contact | Lars Moring |
| Correspondent | Lars Moring PLANMED OY Sorvaajankatu 7 Helsinki, FI 00880 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-11 |
| Decision Date | 2013-02-01 |
| Summary: | summary |