510(k) Report

Devices descending from K960613

914 later devices reach GE Advantage Windows Review Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+12K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+12K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+12K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+12K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+12K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+12K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+12K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+12K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+12K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+12K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+12K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+12K202789Monaco Rtp SystemElekta Solutions AB20213—
+12K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+12K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+12K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+13K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+13K261306AI Contouring (VA10A)Varian Medical Systems20260—
+13K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+13K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+13K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+13K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+13K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+13K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+13K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+13K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+13K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+13K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+13K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+13K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+13K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+13K241211CoLumboSmart Soft Healthcare20242—
+13K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+13K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+13K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+13K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+13K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+13K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+13K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+13K220497CoLumboSmart Soft Healthcare AD20226—
+13K213787Monaco RTP SystemElekta Solutions AB20222—
+13K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+13K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+13K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+13K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+13K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+13K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+13K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+13K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+14K260748ES-SeriesE-Scopics20260—
+14K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+14K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+14K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+14K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+14K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+14K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+14K250367CoLumboXSmart Soft Healthcare AD20250—
+14K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+14K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+14K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+14K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+14K240793MSKaiMskai20240—
+14K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+14K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+14K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+14K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+14K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+14K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+14K223233Monaco RTP SystemElekta Solutions AB20231—
+14K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+14K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+14K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+15K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+15K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+15K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+15K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+15K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+15K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+15K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+15K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+15K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+15K243702V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20254—
+15K242511V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic…Samsung Medison Co., Ltd.20240—
+15K241971HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20241—
+15K240704ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20243—
+15K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+15K212400SONON Ultrasound Imaging System, Model: SONON 500LHealcerion Co., Ltd.20220—
+15K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+15K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+15K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+15K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+15K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+15K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+15K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+16K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+16K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+16K252018HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s…Samsung Medison Co., Ltd.20260—
+16K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+16K250999V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…Samsung Medison Co., Ltd.20252—
+16K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20242—