510(k) Report

Devices descending from K242239

1 later device reach HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC202501