Name: Predicase
Price: 199 USD

K-number	K163289
Device name	syngo. CT Single Source Dual Energy (twin beam)
Applicant	Siemens Medical Solutions USA, Inc., Ultrasound DI
Product code	JAK
Device class	Class II
Decision date	Feb 9, 2017
Decision	Substantially Equivalent
Regulation	892.1750

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Source

View the full FDA submission: accessdata.fda.gov

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syngo. CT Single Source Dual Energy (twin beam)

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