K051464 is an FDA 510(k) clearance for the PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL). This device is classified as a Unit, X-ray, Extraoral With Timer (Class II - Special Controls, product code EHD).
Submitted by Planmeca Oy (Roselle, US). The FDA issued a Cleared decision on June 24, 2005, 21 days after receiving the submission on June 3, 2005.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K051464 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2005 |
| Decision Date | June 24, 2005 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | EHD — Unit, X-ray, Extraoral With Timer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |