510(k) Report

Devices descending from K980648

672 later devices reach Pro Vision through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+10K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+10K220929ExcelsiorMerit Cro, Inc.20220—
+10K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+10K213838AneuGuideArteryFlow Technology Co., Ltd.20220—
+10K212373Sim&SizeSim&Cure20223—
+10K202229AI MetricsAi Metrics, LLC20200—
+10K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+10K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+10K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+10K190178Monaco RTP SystemElekta, Inc.201945
+10K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+10K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+10K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+10K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+11K262452AutoContour (RADAC V6)Radformation, Inc.20260—
+11K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+11K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+11K260785DS Core CBCT AnatomyDentsply Sirona20261—
+11K252538CEPHX3DOrca Dental AI, Ltd.20260—
+11K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+11K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+11K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+11K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+11K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+11K244012Mosaic (V1.0.1)Navier Medical20250—
+11K243989Second Opinion® 3DPearl, Inc.20253—
+11K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+11K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+11K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+11K241211CoLumboSmart Soft Healthcare20242—
+11K231765Contour ProtégéAIMim Software, Inc.20232—
+11K222664Sim&SizeSim&Cure20232—
+11K220497CoLumboSmart Soft Healthcare AD20226—
+11K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+11K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+11K202789Monaco Rtp SystemElekta Solutions AB20213—
+11K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+12K262127DS Core CBCT AnatomyDentsply Sirona20260—
+12K261210Cleerly PlaqueCleerly, Inc.20260—
+12K260588Cleerly LABSCleerly, Inc.20260—
+12K254096VELMENI for DENTISTS (V4D) 3DVelmeni, Inc.20260—
+12K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+12K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—
+12K250367CoLumboXSmart Soft Healthcare AD20250—
+12K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+12K250035Contour ProtégéAI+Mim Software, Inc.20251—
+12K240793MSKaiMskai20240—
+12K242124Sim&SizeSim&Cure20241—
+12K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+12K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+12K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+12K213787Monaco RTP SystemElekta Solutions AB20222—
+12K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+13K253270Contour ProtégéAI+Mim Software, Inc.20260—
+13K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+13K253122Sim&SizeSim&Cure20250—
+13K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+13K223233Monaco RTP SystemElekta Solutions AB20231—
+13K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+14K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+14K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+14K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+14K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+14K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+15K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+15K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+15K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+16K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+16K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+17K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+18K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—