510(k) Report

Devices descending from K942120

1,037 later devices reach Advantage Windows Diagnostic X-Ray Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+13K243299ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+13K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+13K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+13K241432MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20241—
+13K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+13K233613ACUSON SC2000 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20240—
+13K240516RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+13K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+13K231683inHEART ModelsInheart, Sas20240—
+13K233199ROSA® Shoulder SystemOrthosoft Inc (D/B/A Zimmer Cas)20243—
+13K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+13K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+13K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+13K232521ExactechGPS® Total Ankle ApplicationBlue Ortho20230—
+13K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+13K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+13K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+13K230084HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20231—
+13K223564X-Cube 50, X-Cube 60Alpinion Medical Systems Co., Ltd.20230—
+13K223387V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202311—
+13K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20233—
+13K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+13K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+13K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20223—
+13K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20220—
+13K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.20226—
+13K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20223—
+13K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+13K202789Monaco Rtp SystemElekta Solutions AB20213—
+13K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+13K172162ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare201743—
+13K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+14K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited20260—
+14K261306AI Contouring (VA10A)Varian Medical Systems20260—
+14K260885VERAFEYE Imaging and Guidance System (VF-VIS-002)Luma Vision Limited20260—
+14K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+14K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+14K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+14K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+14K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+14K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+14K253457ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+14K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+14K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+14K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+14K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+14K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+14K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+14K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+14K242444HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20240—
+14K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+14K241211CoLumboSmart Soft Healthcare20242—
+14K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+14K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20232—
+14K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+14K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic…Samsung Medison Co., Ltd.20238—
+14K232617ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.202312
+14K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20235—
+14K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+14K220497CoLumboSmart Soft Healthcare AD20226—
+14K213787Monaco RTP SystemElekta Solutions AB20222—
+14K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+14K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020241
+14K200707ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202025—
+14K193257ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2020261
+14K183575ACUSON S3000, S2000 Diagnostic Ultrasound SystemSiemens Healthineers201926—
+14K180799Clarius Ultrasound ScannerClarius Mobile Health Corp.201811—
+14K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+14K180067ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.201828—
+15K260748ES-SeriesE-Scopics20260—
+15K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+15K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+15K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+15K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+15K253487ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20250—
+15K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+15K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+15K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+15K250367CoLumboXSmart Soft Healthcare AD20250—
+15K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+15K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+15K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+15K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+15K240793MSKaiMskai20240—
+15K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+15K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+15K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20247—
+15K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+15K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound…Siemens Medical Solutions USA, Inc.20234—
+15K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+15K223233Monaco RTP SystemElekta Solutions AB20231—
+15K211859ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.202171
+15K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+15K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+16K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+16K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+16K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+16K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+16K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—