510(k) Report

Devices descending from K983877

328 later devices reach Philips Integris 3D RA Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+7K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+7K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+7K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation20167—
+7K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+7K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+7K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+7K150967XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation201551
+7K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+8K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+8K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+8K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADBrainlab AG20250—
+8K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+8K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+8K233457RUSHutom, Inc.20240—
+8K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+8K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+8K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+8K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+8K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+8K214036AVIEWCoreline Soft Co., Ltd.20224—
+8K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+8K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+8K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+8K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+8K211655aPROMISEExini Diagnostics AB20211—
+8K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+8K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+8K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+8K200899Quantib AI NodeQuantib B.V.20200—
+8K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+8K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+8K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+8K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+8K172863Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation20175—
+8K170909Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation201705
+8K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+8K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+9K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+9K252571mdprostateMediaire GmbH20260—
+9K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+9K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+9K253690LungMapsSiemens Healthineers AG20260—
+9K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+9K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+9K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+9K243689AVIEWCoreline Soft Co., Ltd.20250—
+9K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+9K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+9K233211Aview CacCoreline Soft Co., Ltd.20242—
+9K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+9K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+9K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+9K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+9K220590aPROMISE XExini Diagnostics AB20220—
+9K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+9K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+9K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+9K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+9K181670Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation201841
+9K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+9K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+9K142647mint LesionMint Medical GmbH201523
+10K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+10K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+10K250288TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc.20250—
+10K243696Aview CacCoreline Soft Co., Ltd.20250—
+10K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+10K241211CoLumboSmart Soft Healthcare20242—
+10K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+10K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+10K220929ExcelsiorMerit Cro, Inc.20220—
+10K220497CoLumboSmart Soft Healthcare AD20226—
+10K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+10K202229AI MetricsAi Metrics, LLC20200—
+10K203551Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation202032
+10K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+10K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+10K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+10K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+11K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+11K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+11K250367CoLumboXSmart Soft Healthcare AD20250—
+11K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+11K240793MSKaiMskai20240—
+11K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+11K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+11K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+11K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation202423
+11K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+11K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+11K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+11K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+11K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+11K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+12K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+12K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation20251—
+12K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+12K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+12K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—