510(k) Report

Devices descending from K945512

525 later devices reach HRSW Option for CT Twin Flash through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+15K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+15K253270Contour ProtégéAI+Mim Software, Inc.20260—
+15K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+15K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+15K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+15K250367CoLumboXSmart Soft Healthcare AD20250—
+15K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+15K240793MSKaiMskai20240—
+15K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+15K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+15K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+15K191309syngo.via MI Workflows VB40A, SceniumSiemens Medical Soultions USA, Inc.20199—
+16K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+16K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+16K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+16K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+16K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+16K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+17K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+17K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+17K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+18K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+18K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+19K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+20K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—