K-number	K210645
Device name	RayStation 10.1
Applicant	RaySearch Laboratories AB (PUBL)
Product code	MUJ
Device class	Class II
Decision date	Jun 29, 2021
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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RayStation 10.1

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