Gentuity, LLC
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 4
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | January 31, 2025 |
| K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Im | August 16, 2024 |
| K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | August 8, 2023 |
| K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter | February 20, 2020 |