The following data is part of a premarket notification filed by Planmeca Oy with the FDA for Planmeca Dixi, Digital Intraoral X-ray Imaging System.
| Device ID | K980581 |
| 510k Number | K980581 |
| Device Name: | PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | PLANMECA OY ASENTAJANKATU 6 Helsinki, FI 00880 |
| Contact | Lars Moring |
| Correspondent | Lars Moring PLANMECA OY ASENTAJANKATU 6 Helsinki, FI 00880 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-17 |
| Decision Date | 1998-04-17 |