K-number	K191521
Device name	Radiance 330 Proton Beam Therapy System
Applicant	Protom International Holding Corporation
Product code	LHN
Device class	Class II
Decision date	Sep 27, 2019
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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Radiance 330 Proton Beam Therapy System

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