K-number	K221677
Device name	Synapse 3D Base Tools v6.6
Applicant	Fujifilm Corporation
Product code	LLZ
Device class	Class II
Decision date	Nov 10, 2022
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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Synapse 3D Base Tools v6.6

Everything you need for a 510(k) submission. Nothing you don't.