K-number	K162767
Device name	Sentinel BreastScan II System
Applicant	First Sense Medical, LLC
Product code	LHQ
Device class	Class I
Decision date	Jan 9, 2017
Decision	Substantially Equivalent
Regulation	884.2980

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Source

View the full FDA submission: accessdata.fda.gov

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Sentinel BreastScan II System

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