The following data is part of a premarket notification filed by Planmed Oy with the FDA for Planmed Sophie & Planmed Sophie Classic.
| Device ID | K013656 |
| 510k Number | K013656 |
| Device Name: | PLANMED SOPHIE & PLANMED SOPHIE CLASSIC |
| Classification | System, X-ray, Mammographic |
| Applicant | PLANMED OY 1250 GREENBRIAR, SUITE A Addison, IL 60101 |
| Contact | Bob Pienkowski |
| Correspondent | Bob Pienkowski PLANMED OY 1250 GREENBRIAR, SUITE A Addison, IL 60101 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-06 |
| Decision Date | 2002-01-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430035430055 | K013656 | 000 |