K-number	K171049
Device name	Real Time Image Gating System for Proton Beam Therapy Systems
Applicant	Hitachi, Ltd. Healthcare
Product code	LHN
Device class	Class II
Decision date	Dec 26, 2017
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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Real Time Image Gating System for Proton Beam Therapy Systems

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