# Gentuity, LLC

- Location (FDA's records): Sudbury, MA
- FDA decisions: 4 (2020–2025): 4 510(k) clearances
- Product codes: DQO (2), NQQ (2)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Lightlab Imaging, Inc.: 2 (https://510kreport.com/company/lightlab-imaging)

## Its most-cited devices
- K242239: HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) (2024), cited by 1
- K230620: Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (2023), cited by 1
- K192922: Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter (2020), cited by 1

## Recent decisions
- K242966: Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (Jan 31, 2025)
- K242239: HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) (Aug 16, 2024)
- K230620: Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (Aug 8, 2023)
- K192922: Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter (Feb 20, 2020)

Source page: https://510kreport.com/company/gentuity