510(k) Report

Devices descending from K842308

62 later devices reach 12SSL-SC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162012CARESCAPE Central Station V2GE Healthcare201676
+1K980495Muse Cardiovascular Information SystemMarquette Medical Systems, Inc.199861—
+2K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc.20203—
+2K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.20182—
+2K992637Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn1999601
+3K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20250—
+3K232354Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc.20240—
+3K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+3K050614Muse Cardiology Information SystemGe Medical Systems Information Technologies2005201
+3K031970Infinity MegacareSiemens Medical Solutions USA, Inc.200314—
+3K023100Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn200223—
+4K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+4K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+4K072502Modification to: Muse Cardiology Information SystemGe Medical Systems Information Technologies2007192
+4K063628Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopyGe Healthcare Integrated IT Solutions2006183
+4K061905Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd.20068—
+4K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc.2005131
+4K042525Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy…Ge Medical Systems Information Technologies2004223
+5K141946Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20153—
+5K140869DCAS IGp&P Co., Ltd.20140—
+5K120770QT Guard Plus Analysis SystemGe Medical Systems Information Technologies20120—
+5K113515Horizon Cardiology Ecg ManagementMckesson Israel, Ltd.201272
+5K112720Mckesson Horizon CardiologyMckesson Israel, Ltd.20123—
+5K103181Zenis, Picture Archiving and Communications SystemGenoray Co., Ltd.20110—
+5K110132Muse Cardiology Information SystemGe Medical Systems Information Technologies, Inc.201115—
+5K083639Muse Cardiology Information System with VmwareGe Medical Systems Information Technologies2009171
+5K081630Mammo WorkstationImage Diagnost International GmbH20084—
+5K081018Syngo Dynamics Version 7.0Siemens Medical Solutions20088—
+5K063006GE Logiq WorksGeneral Electric Co.20060—
+6K171517Digital ElectrocardiographBiocare Bio-Medical Equipment Co., Ltd.20180—
+6K160092Digital ElectrocardiographShenzhen Biocare Bio-Medical Equipment Co., Ltd.20161—
+6K151850McKesson CardiologyMckesson Israel, Ltd.20152—
+6K142288MAC 800 Resting ECG Analysis SystemGe Medical Systems China Co., Ltd.20140—
+6K133882Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc.201491
+6K133534Mckesson Cardiology Ecg MobileMckesson Israel, Ltd.20146—
+6K132188Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc.20130—
+6K130155Muse Cardiology Information SystemGe Medical Systems Information Technologies, Inc.20133—
+6K123575MammoworkstationImage Diagnost International GmbH20132—
+6K123466Healthview Ecg ManagerLumedx20120—
+6K102150Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc.201077
+7K233266Mediblu Ecg SystemMediblu Medical, LLC20240—
+7K181720Epiphany Cardio Server MobileEpiphany Healthcare, LLC20180—
+7K181080McKesson CardiologyChange Healthcare Israel, Ltd.20181—
+7K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien201601
+7K152881Sentinel Cardiology Information Management SystemSpacelabs Healthcare, Ltd.201602
+7K152993MUSE Cardiology Information SystemGe Medical Systems Information Technologies, Inc.201611
+7K151774CARESTREAM Vue MotionCarestream Health, Inc.201541
+7K143361Mammo WorkstationGE Healthcare20151—
+7K123922Syngo DynamicsSiemens Medical Solutions USA, Inc.20135—
+7K120514CardiopacsLumedx20120—
+8K212528Change Healthcare CardiologyChange Healthcare Israel, Ltd.20210—
+8K201060Cordiana Dx16Cordiana Medical Informatics AG20200—
+8K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+8K171053syngo Dynamics Version VA30Siemens Healthcare GmbH20174—
+8K160937SenolrisGE Healthcare20160—
+9K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+9K220832syngo Dynamics (Version VA40E)Siemens Medical Solutions USA, Inc.20223—
+9K200822BraidBraid.Health20201—
+10K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+10K222428Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc.20222—
+11K242551syngo Dynamics (Version VA41D)Siemens Healthcare GmbH20251—
+12K253689syngo Dynamics (VA41F)Siemens Healthcare GmbH20260—