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510(k) K242098

Device
Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)
Applicant
Shenzhen Vivolight Medical Device & Technology Co., Ltd.
510(k) number
K242098
Product code
NQQ
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-11
Date received
2024-07-18
Regulation
892.1560
Classification name
System, Imaging, Optical Coherence Tomography (Oct)
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gao Pengyang
Address
Rm. 511-A, 5th Floor, Block B, Bldg. R2, High-Tech Indus Strial Park, # 020, S. Seventh Rd. Gaoxin Community, Shenzhen CN 518055 518055

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K210458OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging SystemABBOTT MEDICAL2021-06-08
K203578OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography SystemPerimeter Medical Imaging Ai, Inc.2021-02-25