K111989 is an FDA 510(k) clearance for the CORONIS FUSION 4MP DL. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Barco N.V. (Kortrijk, BE). The FDA issued a Cleared decision on September 22, 2011, 71 days after receiving the submission on July 13, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K111989 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2011 |
| Decision Date | September 22, 2011 |
| Days to Decision | 71 days |
| Submission Type | Special |
| 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 |