FDA 510(k) clearance · back to tracker

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

Shenzhen Vivolight Medical Device & Technology Co., Ltd. cleared K242098 on 2025-04-11, decision: substantially equivalent

K-number

K242098

Sponsor

Shenzhen Vivolight Medical Device & Technology Co., Ltd.

Device

Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-04-11

Product code

NQQ

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1560

Official FDA record

Open K242098on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.