Name: Predicase
Price: 199 USD

K-number	K063493
Device name	I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0
Applicant	Boston Scientific Corp
Product code	IYN
Device class	Class II
Decision date	Dec 21, 2006
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0

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