K-number	K080555
Device name	SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
Applicant	Ivu Imaging Corporation
Product code	ITX
Device class	Class II
Decision date	Jun 3, 2008
Decision	Substantially Equivalent
Regulation	892.1570

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View the full FDA submission: accessdata.fda.gov

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SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)

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