The following data is part of a premarket notification filed by Planmed Oy with the FDA for Planned Sophied Classic.
| Device ID | K962105 |
| 510k Number | K962105 |
| Device Name: | PLANNED SOPHIED CLASSIC |
| Classification | System, X-ray, Mammographic |
| Applicant | PLANMED OY ASENTAJANKATU 6 Helsinki, FI 00880 |
| Contact | Lars Moring |
| Correspondent | Lars Moring PLANMED OY ASENTAJANKATU 6 Helsinki, FI 00880 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-31 |
| Decision Date | 1997-02-05 |