K-number	K152244
Device name	RADspeed Pro
Applicant	Shimadzu Corporation
Product code	KPR
Device class	Class II
Decision date	Jun 20, 2016
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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RADspeed Pro

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