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510(k) K232828

IMAGEnet6 Ophthalmic Data System by Topcon Corporation — Product Code NFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2024
Date Received
September 13, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Management, Ophthalmic
Device Class
Class II
Regulation Number
892.2050
Review Panel
OP
Submission Type

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