Name: Predicase
Price: 199 USD

K-number	K182596
Device name	Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System
Applicant	Canon Medical Systems Corporation
Product code	IYN
Device class	Class II
Decision date	Nov 2, 2018
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

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