510(k) Report

Devices descending from K040970

420 later devices reach Leonardo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K254184syngo Application SoftwareSiemens Medical Solutions USA, Inc.20260—
+12K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+12K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+12K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary Care Diagnostics20250—
+12K250367CoLumboXSmart Soft Healthcare AD20250—
+12K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+12K240793MSKaiMskai20240—
+12K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+12K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+12K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+12K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+12K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+13K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+13K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+13K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+13K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+14K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+14K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+15K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+16K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—