510(k) Report

Devices descending from K013561

113 later devices reach Lightspeed 4.0 CT Scanner System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K250650SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta, Ltd.20250—
+10K243523NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSiemens Medical Solutions USA, Inc.20251—
+10K241295SOMATOM On.siteSiemens Medical Solutions USA, Inc.20240—
+10K233750ECG-less CardiacGe Medical Systems, LLC20240—
+10K211373SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X.…Siemens Medical Solutions USA, Inc.2021123
+11K251061NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSiemens Medical Solutions USA, Inc.202503
+11K233650SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM…Siemens Medical Solutions USA, Inc.202451
+11K232206SOMATOM Pro.PulseSiemens Medical Solutions USA, Inc.20232—
+11K230162uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202324
+12K253574SOMATOM X.cite; SOMATOM X.ceedSiemens Medical Solutions USA, Inc.20260—
+12K250822SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM…Siemens Medical Solutions USA, Inc.20251—
+12K241079uCT 780Shanghai United Imaging Healthcare Co., Ltd.202512
+13K253173uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd.202601