FDA 510(k)

Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter

K-번호: K242966 · 2025-01-31

결정일2025-01-31

제품 코드DQO

자문 위원회CV

결정Substantially Equivalent

기기 요약

Gentuity® HF-OCT Imaging System with Vis-Rx Prime® 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 2025-01-31 under 510(k) number K242966. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

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. The listed applicant is Gentuity, LLC. The 510(k) number is K242966.

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

Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter received FDA 510(k) clearance on 2025-01-31, under 510(k) number K242966.

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

The FDA product code for Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter is DQO.

Gentuity, LLC를 신청인으로 등재한 기타 기록

K242239HF-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 K192922Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.