# K230620: Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Gentuity, LLC
- Decided: Aug 8, 2023 after 155 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K123369 (2013). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192922: Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter, Gentuity, LLC (2020) Summary page 5.

## Most influential descendants
- K242239: HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) (2024), 1 descendant of its own
- K242966: Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (2025), 0 descendants of its own

## Indications for use
The Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter is intended for intravascular imaging and is indicated for use in coronary arteries in patients who are candidates for transluminal interventional procedures. The Vis-Rx Micro-Imaging Catheter is intended for use in vessels 1.3 to 6.0 mm in diameter. The Vis-Rx Micro-Imaging Catheter is not intended for use in a target vessel that has undergone a previous bypass procedure.

Source page: https://510kreport.com/device/K230620
Methodology: https://510kreport.com/methodology