510(k) Report

Devices descending from K230620

2 later devices reach Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242239HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30…Gentuity, LLC20241—
+2K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC202501