510(k) Report

Devices descending from K070397

7 later devices reach Dgscope, Release 1.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080608Digital LightboxBrainlab AG20086—
+2K093117Digital LightboxBrainlab AG200952
+3K153653DICOM ViewerBrainlab AG20164—
+4K191014Elements ViewerBrainlab AG20203—
+5K254265Helion Viewer SuiteVideomed Srl ( a Baxter Healthcare Corp company)20260—
+5K232759Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG202411
+6K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart…Brainlab AG20250—