K231075 is an FDA 510(k) clearance for the Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option). This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on June 20, 2023, 67 days after receiving the submission on April 14, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K231075 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2023 |
| Decision Date | June 20, 2023 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | IZI — System, X-ray, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |