510(k) Report

Devices descending from K153653

4 later devices reach DICOM Viewer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191014Elements ViewerBrainlab AG20203—
+2K254265Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company)20260—
+2K232759Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG202411
+3K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG20250—