510(k) Report

Devices descending from K010042

214 later devices reach CT Perfusion 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K240793MSKaiMskai20240—
+13K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+13K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+13K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+13K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+13K201202MI View&GOSiemens Medical Solutions USA, Inc.20203—
+14K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+14K242300MI View&GOSiemens Medical Solutions USA, Inc.20241—
+14K222172MI View&GOSiemens Medical Solutions USA, Inc.20222—
+14K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+15K254016MI View&GOSiemens Medical Solutions USA, Inc.20260—
+15K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+16K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20242—
+17K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20251—