The following data is part of a premarket notification filed by Planmed Oy with the FDA for Planmed Clarity 2d And Clarity S.
| Device ID | K192317 |
| 510k Number | K192317 |
| Device Name: | Planmed Clarity 2D And Clarity S |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | Planmed Oy Sorvaajankatu 7 Helsinki, FI 00880 |
| Contact | Lars Moring |
| Correspondent | Lars Moring Planmed Oy Sorvaajankatu 7 Helsinki, FI 00880 |
| Product Code | MUE |
| CFR Regulation Number | 892.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-26 |
| Decision Date | 2020-10-23 |