K-number	DEN170092
Device name	Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System
Applicant	Fluoptics
Product code	QDG
Device class	Class II
Decision date	Nov 2, 2018
Decision	Not Substantially Equivalent
Regulation	878.4550

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View the full FDA submission: accessdata.fda.gov

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Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System

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