510(k) Report

Devices descending from K923077

518 later devices reach Advantage Windows 3D Option and Dentascan Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+9K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+9K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+9K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201821—
+9K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+9K163539Ez3D-i / E3Ewoosoft Co., Ltd.20161—
+9K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+10K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+10K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+10K252539Tempus PixelArterys, Inc.20250—
+10K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADBrainlab AG20250—
+10K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+10K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+10K240791ADAS 3DAdas3D Medical S.L.20241—
+10K241440HealthCCSngNano-X AI, Ltd.20240—
+10K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+10K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+10K231683inHEART ModelsInheart, Sas20240—
+10K233080HealthFLDNano-X AI, Ltd.20240—
+10K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+10K231765Contour ProtégéAIMim Software, Inc.20232—
+10K230112CAC SoftwareImbio, Inc.20230—
+10K230223iCAC DeviceBunkerhill, Inc.20236—
+10K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+10K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+10K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+10K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+10K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+10K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+10K213787Monaco RTP SystemElekta Solutions AB20222—
+10K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+10K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+10K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+10K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+10K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+10K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+10K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+10K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+10K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+10K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+11K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+11K252571mdprostateMediaire GmbH20260—
+11K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+11K253969ADAS 3DAdas3D Medical S.L.20260—
+11K253690LungMapsSiemens Healthineers AG20260—
+11K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+11K260166Bunkerhill Contrast CACBunkerHill Health20260—
+11K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+11K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+11K250662Bunkerhill MACBunkerHill Health20250—
+11K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+11K250035Contour ProtégéAI+Mim Software, Inc.20251—
+11K243229Bunkerhill AVCBunkerHill Health20253—
+11K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+11K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+11K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+11K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+11K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+11K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+11K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+11K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+11K223233Monaco RTP SystemElekta Solutions AB20231—
+11K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+11K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+11K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+11K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+11K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+11K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+12K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+12K253270Contour ProtégéAI+Mim Software, Inc.20260—
+12K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+12K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+12K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+12K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+12K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+12K241211CoLumboSmart Soft Healthcare20242—
+12K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+12K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+12K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+12K220497CoLumboSmart Soft Healthcare AD20226—
+12K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+12K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+13K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+13K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+13K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+13K250367CoLumboXSmart Soft Healthcare AD20250—
+13K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+13K240793MSKaiMskai20240—
+13K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+13K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+13K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+13K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+13K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+13K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+14K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+14K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+14K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+14K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+14K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+14K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—