Sudbury, MA, US · 4 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DQO | — | — | — | 2 | 2025-01-31 |
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | Class II | Radiology | 2 | 2024-08-16 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-03-23 | Class II | Ongoing | Z-1823-2026 | 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 version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx P… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-01-31 | K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | DQO | — | — |
| 2024-08-16 | K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) | NQQ | Class II | Radiology |
| 2023-08-08 | K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | DQO | — | — |
| 2020-02-20 | K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter | NQQ | Class II | Radiology |