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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Gentuity, LLC. It received FDA 510(k) clearance on 2020-02-20 under 510(k) 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. The listed applicant is Gentuity, LLC. The 510(k) number is K192922.

When did Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter receive FDA 510(k) clearance?

Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter received FDA 510(k) clearance on 2020-02-20, under 510(k) number K192922.

Who is the listed applicant for Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter?

The FDA 510(k) record lists Gentuity, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Gentuity, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterK242239HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))K230620Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter

Related Devices (Code: NQQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)ABBOTT MEDICALK251730LIA Console (542-7)Leadoptik, Inc.K253101HyperVue™ Imaging System - IntegratedSpectrawave, Inc.K252851deepLive (OSP12 + DMS)Damae MedicalK251198HyperVue™ SoftwareSpectrawave, Inc.K250684OPUSWAVE Dual Sensor Imaging SystemTerumo Cardiovascular Systems Thi Plant

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.

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