The following data is part of a premarket notification filed by Planmed Oy with the FDA for Planmed Cytoguide.
| Device ID | K923471 |
| 510k Number | K923471 |
| Device Name: | PLANMED CYTOGUIDE |
| Classification | System, X-ray, Mammographic |
| Applicant | PLANMED OY ASENTAJANKATU 6 Helsinki, FI 00880 |
| Contact | Ismo Seppa |
| Correspondent | Ismo Seppa 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 | 1992-07-14 |
| Decision Date | 1992-11-24 |