510(k) Report

Devices descending from K083524

117 later devices reach Syngo Dual Energy with Extended Funationally through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+7K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+7K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+7K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+8K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+8K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+8K241211CoLumboSmart Soft Healthcare20242—
+8K220497CoLumboSmart Soft Healthcare AD20226—
+8K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+9K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+9K250367CoLumboXSmart Soft Healthcare AD20250—
+9K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+9K240793MSKaiMskai20240—
+9K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+9K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+9K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+10K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—