510(k) Report

Devices descending from K032350

2 later devices reach Infrared Sciences Breastscan IR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162767Sentinel BreastScan II SystemFirst Sense Medical, LLC20170—
+1K160573FirstSense Breast ExamFirst Sense Medical, LLC20160—