The following data is part of a premarket notification filed by Planmed Oy with the FDA for Planmed Clarity.
| Device ID | K163328 |
| 510k Number | K163328 |
| Device Name: | Planmed Clarity |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | Planmed Oy Sorvaajankatu 7 Helsinki, FI Fi-00880 |
| Contact | Lars Moring |
| Correspondent | Lars Moring Planmed Oy Sorvaajankatu 7 Helsinki, FI 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 | 2016-11-28 |
| Decision Date | 2017-12-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035430079 | K163328 | 000 |