K162991 is an FDA 510(k) clearance for the YELLOW 560 Fluorescence Module. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on July 24, 2017, 270 days after receiving the submission on October 27, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K162991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | October 27, 2016 |
| Decision Date | July 24, 2017 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZI — System, X-ray, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |