510(k) Report

Devices descending from K120579

122 later devices reach Somatom Definition Edge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K251061NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSiemens Medical Solutions USA, Inc.202503
+7K241211CoLumboSmart Soft Healthcare20242—
+7K233650SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM…Siemens Medical Solutions USA, Inc.202451
+7K232206SOMATOM Pro.PulseSiemens Medical Solutions USA, Inc.20232—
+7K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+7K230162uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202324
+7K220497CoLumboSmart Soft Healthcare AD20226—
+7K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+8K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+8K253574SOMATOM X.cite; SOMATOM X.ceedSiemens Medical Solutions USA, Inc.20260—
+8K250822SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM…Siemens Medical Solutions USA, Inc.20251—
+8K250367CoLumboXSmart Soft Healthcare AD20250—
+8K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+8K241079uCT 780Shanghai United Imaging Healthcare Co., Ltd.202512
+8K241757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20251—
+8K240793MSKaiMskai20240—
+8K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+8K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+8K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+9K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+9K253173uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202601
+9K251805syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20250—