The following data is part of a premarket notification filed by Planmed Oy with the FDA for Planmed Sophie & Sophie Classic (with Digispot And Cytoguide).
| Device ID | K021945 |
| 510k Number | K021945 |
| Device Name: | PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) |
| Classification | System, X-ray, Mammographic |
| Applicant | PLANMED OY 100 NORTH GRAY AVE. SUITE A Roselle, IL 60172 |
| Contact | Bob Pienkowski |
| Correspondent | Bob Pienkowski PLANMED OY 100 NORTH GRAY AVE. SUITE A Roselle, IL 60172 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-13 |
| Decision Date | 2003-02-21 |