K-number	K122878
Device name	HD-IVUS ULTRASOUND IMAGING SYSTEM
Applicant	Silicon Vally Medical Instruments, Inc.
Product code	OBJ
Device class	Class II
Decision date	Jan 11, 2013
Decision	Substantially Equivalent
Regulation	870.1200

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Source

View the full FDA submission: accessdata.fda.gov

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HD-IVUS ULTRASOUND IMAGING SYSTEM

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