510(k) Report

Devices descending from K230421

3 later devices reach SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233657NAEOTOM AlphaSiemens Medical Solutions USA, Inc.20242—
+2K243523NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSiemens Medical Solutions USA, Inc.20251—
+3K251061NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSiemens Medical Solutions USA, Inc.202503