K-number	K140445
Device name	DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC
Applicant	Imaging Sciences International, LLC
Product code	LLZ
Device class	Class II
Decision date	Apr 23, 2014
Decision	Substantially Equivalent
Regulation	892.2050

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View the full FDA submission: accessdata.fda.gov

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DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC

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