Name: Predicase
Price: 199 USD

K-number	K093891
Device name	AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2
Applicant	Toshibamedical Systems Corporation
Product code	JAK
Device class	Class II
Decision date	Nov 18, 2010
Decision	Substantially Equivalent
Regulation	892.1750

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Source

View the full FDA submission: accessdata.fda.gov

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AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2

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