K141607 is an FDA 510(k) clearance for the DENTAL IMAGING SOFTWARE. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Trophy (Marne La Vallee Cedex 2, FR). The FDA issued a Cleared decision on September 18, 2014, 94 days after receiving the submission on June 16, 2014.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K141607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2014 |
| Decision Date | September 18, 2014 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |