The following data is part of a premarket notification filed by Planmed Oy with the FDA for Planmed Nuance Digiguide.
| Device ID | K121963 |
| 510k Number | K121963 |
| Device Name: | PLANMED NUANCE DIGIGUIDE |
| Classification | Full Field Digital, System, X-ray, Mammographic |
| Applicant | PLANMED OY ASENTAJANKATU 6 SORVAAJANKATU 7 Helsinki, FI Fi-00880 |
| Contact | Lars Moring |
| Correspondent | Lars Moring PLANMED OY ASENTAJANKATU 6 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 | 2012-07-05 |
| Decision Date | 2012-11-21 |
| Summary: | summary |