510(k) Report

Devices descending from K897191

4 later devices reach Bsi Model Tip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990416Omnicorder Bioscan SystemOmnicorder Technologies, Inc.19993—
+2K032350Infrared Sciences Breastscan IR SystemInfrared Sciences Corp.20042—
+3K162767Sentinel BreastScan II SystemFirst Sense Medical, LLC20170—
+3K160573FirstSense Breast ExamFirst Sense Medical, LLC20160—