Name: Predicase
Price: 199 USD

K-number	K180572
Device name	AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10
Applicant	Supersonic Imagine
Product code	IYN
Device class	Class II
Decision date	May 29, 2018
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10

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