510(k) K230620

Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter by Gentuity, LLC — Product Code DQO

K230620 is an FDA 510(k) premarket notification submitted by Gentuity, LLC for the device "Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter". The FDA issued a decision of Substantially Equivalent on August 8, 2023. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Gentuity, LLC has at least 3 other 510(k) clearances on record.