Gentuity, LLC
FDA 510(k) & PMA Approved Devices — 4 products
Total Devices4
Categories2
Latest Approval2025-01-31
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | DQO | 2025-01-31 | View |
| 510(k) | K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) | NQQ | 2024-08-16 | View |
| 510(k) | K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | DQO | 2023-08-08 | View |
| 510(k) | K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter | NQQ | 2020-02-20 | View |
No matching devices.