510(k) Report

Devices descending from K990416

3 later devices reach Omnicorder Bioscan System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032350Infrared Sciences Breastscan IR SystemInfrared Sciences Corp.20042—
+2K162767Sentinel BreastScan II SystemFirst Sense Medical, LLC20170—
+2K160573FirstSense Breast ExamFirst Sense Medical, LLC20160—