HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))— 510(k) K242239

Name: FDA 510(k) clearance K242239
Creator: U.S. Food and Drug Administration
Published: 2024-08-16

Substantially Equivalent

Gentuity, LLC

FDA 510(k) clearance K242239 for HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)), Substantially Equivalent on 2024-08-16. Applicant: Gentuity, LLC. Device class: 2.

Clearance details

Applicant: Gentuity, LLC
Product code: Code NQQ
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2024-07-30
Decision date: 2024-08-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Sudbury, MA, US

Download summary PDF View on FDA.gov ↗

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