K-number	K113102
Device name	ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING
Applicant	Nucletron
Product code	MUJ
Device class	Class II
Decision date	Dec 12, 2011
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING

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