K242966 is an FDA 510(k) clearance for the Gentuity® HF-OCT Imaging System with Vis-Rx Prime® 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 January 31, 2025, 127 days after receiving the submission on September 26, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K242966 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2024 |
| Decision Date | January 31, 2025 |
| Days to Decision | 127 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 |