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

Substantially Equivalent

Gentuity, LLC

Clearance details

Applicant: Gentuity, LLC
Product code: Code NQQ
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 ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.