Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
K-Number: K192922 · 2020-02-20
ApplicantGentuity, LLC
Decision Date2020-02-20
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter is a medical device manufactured by Gentuity, LLC. It received FDA 510(k) clearance on 2020-02-20 under approval number K192922. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter?
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter is a medical device that received FDA 510(k) clearance on 2020-02-20. It is manufactured by Gentuity, LLC. The 510(k) number is K192922.
When was Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter approved by the FDA?
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter received FDA 510(k) clearance on 2020-02-20, under approval number K192922.
What company makes Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter?
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter is manufactured by Gentuity, LLC.
What is the FDA product code for Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter?
The FDA product code for Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter is NQQ.
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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.