K-number	DEN220014
Device name	RefleXion Medical Radiotherapy System (RMRS)
Applicant	Reflexion Medical, Inc.
Product code	QVA
Device class	Class II
Decision date	Feb 1, 2023
Decision	Not Substantially Equivalent
Regulation	892.5060

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View the full FDA submission: accessdata.fda.gov

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RefleXion Medical Radiotherapy System (RMRS)

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