510(k) Report

Devices descending from K193473

3 later devices reach LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231328LUX-Dx II (M302); LUX-Dx II+ (M312)Boston Scientific Corp202316
+1K210608LUX-Dx Insertable Cardiac MonitorBoston Scientific Corporation20210—
+2K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation20250—