K113419 is an FDA 510(k) clearance for the CS IMAGING. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Trophy (Croissy-Beaubourg, FR). The FDA issued a Cleared decision on February 16, 2012, 90 days after receiving the submission on November 18, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K113419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2011 |
| Decision Date | February 16, 2012 |
| Days to Decision | 90 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 |