K243645 is an FDA 510(k) clearance for the IC-Flow™ Imaging System 2.0. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Diagnostic Green GmbH (Kirchheim B. München, DE). The FDA issued a Cleared decision on September 22, 2025, 300 days after receiving the submission on November 26, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K243645 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2024 |
| Decision Date | September 22, 2025 |
| Days to Decision | 300 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 |