K230620 is an FDA 510(k) clearance for the Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Gentuity, LLC (Sudbury, US). The FDA issued a Cleared decision on August 8, 2023, 155 days after receiving the submission on March 6, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K230620 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2023 |
| Decision Date | August 08, 2023 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO - Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |