510(k) Report

Devices descending from K061645

7 later devices reach Magpro, Model R30 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162873MEP MonitorTonica Elektronik A/S20170—
+1K160280MagPro R20Tonica Elektronik A/S20161—
+1K150220STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-FastEb Neuro S.P.A.20150—
+1K091940Magpro, Models R30 with Magoption, X100, X100 with MagoptionTonica Elektronik A/S20102—
+1K071821Coils, Models MCF-B65, MCF-75, MCF-125 and Cool-B65Tonica Elektronik A/S20070—
+2K242345Delphi StimulatorQuantalx Neuroscience20240—
+2K192823Mega-TMSSoterix Medical, Inc.20210—