K980581 is an FDA 510(k) clearance for the PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM. This device is classified as a Unit, X-ray, Extraoral With Timer (Class II - Special Controls, product code EHD).
Submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on April 17, 1998, 59 days after receiving the submission on February 17, 1998.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K980581 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 1998 |
| Decision Date | April 17, 1998 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | EHD — Unit, X-ray, Extraoral With Timer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |