510(k) Report

Devices descending from K904519

438 later devices reach Agfa Diagnostic Center (Adc) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+15K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+15K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+15K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+15K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+15K250035Contour ProtégéAI+Mim Software, Inc.20251—
+15K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+15K241211CoLumboSmart Soft Healthcare20242—
+15K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+15K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+15K220497CoLumboSmart Soft Healthcare AD20226—
+15K213787Monaco RTP SystemElekta Solutions AB20222—
+15K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+15K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+16K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+16K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+16K253270Contour ProtégéAI+Mim Software, Inc.20260—
+16K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+16K250367CoLumboXSmart Soft Healthcare AD20250—
+16K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+16K240793MSKaiMskai20240—
+16K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+16K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+16K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+16K223233Monaco RTP SystemElekta Solutions AB20231—
+16K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+17K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+17K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+17K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+17K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+17K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+17K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+18K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+18K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+18K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+19K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+19K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+20K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+21K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—