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FDA 510(k)

Cornaris 體內影像系統 (P80-E)；Cornaris 體內影像系統 (Mobile-E)；LumenCross 影像導管 (F2)

K 號：K242098 · 2025-04-11

申請人Shenzhen Vivolight Medical Device & Technology Co., Ltd.
決定日期2025-04-11
產品代碼NQQ
諮詢委員會RA
決定相當於

器材摘要

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Vivolight Medical Device & Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K242098. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)?

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Shenzhen Vivolight Medical Device & Technology Co., Ltd.. The 510(k) number is K242098.

When did Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) receive FDA 510(k) clearance?

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) received FDA 510(k) clearance on 2025-04-11, under 510(k) number K242098.

Who is the listed applicant for Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)?

The FDA 510(k) record lists Shenzhen Vivolight Medical Device & Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)?

The FDA product code for Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) is NQQ.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：NQQ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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