Name: Predicase
Price: 199 USD

K-number	K122537
Device name	PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0
Applicant	Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical
Product code	IYN
Device class	Class II
Decision date	Apr 12, 2013
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0

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