Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
Gentuity, LLC
GENTUITY, LLC
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011578544 | 3011578544 | GENTUITY, LLC | 1 | N | 2026-01-01 | 142 North Road Suite G Sudbury MA US 01776 |
| 3021630097 | 3021630097 | GENTUITY, LLC | 1 | N | 2026-01-01 | 28 Crosby Drive Bedford MA US 01730 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 267098 | 1006957363 | K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | DQO | 2025-01-31 |
| 267098 | 1059696353 | K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | DQO | 2023-08-08 |
| 267098 | 1375218627 | K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter | NQQ | 2020-02-20 |
| 302439 | 1375218627 | K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter | NQQ | 2020-02-20 |
Product Codes Associated With Registrations
PMN
GUDID
Vis-Rx Prime - 1.8F Rapid exchange micro-imaging high-frequency OCT catheter kit - US
2025-04-09
Gentuity - Gentuity Off-line Review Station includes computer, monitor, keyboard, and mouse.
2022-08-17
Gentuity HF-OCT Imaging System - Gentuity OCT imaging console, including optical engine, PC, PIM with umbilical, 2 monitors (one with touch screen) and keyboard/mouse.
2021-06-22
Vis-Rx - 1.8F Rapid exchange micro-imaging high frequency OCT catheter kit - US
2021-02-11