Name: Predicase
Price: 199 USD

K-number	K191467
Device name	Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0
Applicant	Canon Medical Systems Corporation
Product code	IYN
Device class	Class II
Decision date	Jul 19, 2019
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0

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