Name: Predicase
Price: 199 USD

K-number	K152224
Device name	Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)
Applicant	Ion Beam Application S.A.
Product code	LHN
Device class	Class II
Decision date	Aug 9, 2016
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)

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