K-number	K171370
Device name	IMAGEnet 6 Ophthalmic Data System
Applicant	Topcon Corporation
Product code	NFJ
Device class	Class II
Decision date	Nov 1, 2017
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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IMAGEnet 6 Ophthalmic Data System

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