The following data is part of a premarket notification filed by Planmeca Usa, Inc. with the FDA for Planmed Sophie.
| Device ID | K904953 |
| 510k Number | K904953 |
| Device Name: | PLANMED SOPHIE |
| Classification | System, X-ray, Mammographic |
| Applicant | PLANMECA USA, INC. ASENTAJASNKATU 6 00810 HELSINKI Finland, FI |
| Contact | Matti Spolander |
| Correspondent | Matti Spolander PLANMECA USA, INC. ASENTAJASNKATU 6 00810 HELSINKI Finland, FI |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-05 |
| Decision Date | 1991-04-18 |