Cornaris Intravascular Imaging System (P80-E) +2 more— 510(k) K242098

Name: FDA 510(k) clearance K242098
Creator: U.S. Food and Drug Administration
Published: 2025-04-11

Substantially Equivalent

Shenzhen Vivolight Medical Device & Technology Co., Ltd.

FDA 510(k) clearance K242098 for Cornaris Intravascular Imaging System (P80-E) +2 more, Substantially Equivalent on 2025-04-11. Applicant: Shenzhen Vivolight Medical Device & Technology Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)
Applicant: Shenzhen Vivolight Medical Device & Technology Co., Ltd.
Product code: Code NQQ
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2024-07-18
Decision date: 2025-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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