Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
K-Number: K242966 · 2025-01-31
ApplicantGentuity, LLC
Decision Date2025-01-31
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter is a medical device manufactured by Gentuity, LLC. It received FDA 510(k) clearance on 2025-01-31 under approval number K242966. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter?
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter is a medical device that received FDA 510(k) clearance on 2025-01-31. It is manufactured by Gentuity, LLC. The 510(k) number is K242966.
When was Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter approved by the FDA?
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter received FDA 510(k) clearance on 2025-01-31, under approval number K242966.
What company makes Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter?
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter is manufactured by Gentuity, LLC.
What is the FDA product code for Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter?
The FDA product code for Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter is DQO.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.