FDA 510(k) Applications Submitted by Edwin Rule

FDA 510(k) Number Submission Date Device Name Applicant
K242239 07/30/2024 HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) Gentuity, LLC
K162131 08/01/2016 ExSpiron 1Xi Respiratory Motion Inc.
K242966 09/26/2024 Gentuity« HF-OCT Imaging System with Vis-Rx Prime« Micro-Imaging Catheter Gentuity, LLC


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