Gentuity, LLC
Medical device manufacturer in Sudbury, MA.
4510(k) clearances
0PMA approvals
1recalls
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterDQO · Traditional | 01/31/2025SE |
| K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30…NQQ · Special | 08/16/2024SE |
| K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterDQO · Traditional | 08/08/2023SE |
| K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging CatheterNQQ · Traditional | 02/20/2020SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1823-2026 Class II | Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software… | 03/23/2026Open, Classified |