510(k) K162767

Sentinel BreastScan II System by First Sense Medical, LLC — Product Code LHQ

K162767 is an FDA 510(k) premarket notification submitted by First Sense Medical, LLC for the device "Sentinel BreastScan II System". The FDA issued a decision of Substantially Equivalent on January 9, 2017. The device falls under product code LHQ (System, Telethermographic (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2980. First Sense Medical, LLC has at least 1 other 510(k) clearance on record.