Clearance Summary
Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) received FDA 510(k) clearance under submission number K242098, sponsored by Shenzhen Vivolight Medical Device & Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-04-11.
- Submission: K242098
- Applicant / Sponsor: Shenzhen Vivolight Medical Device & Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2025-04-11
Classification & Regulation
This clearance is catalogued under FDA product code NQQ and 21 CFR 892.1560, within the Radiology review panel as a Class II device.