510(k) Report

Devices descending from K232363

2 later devices reach Viz HDS, Viz Volume Plus, Viz ICH+ through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260406Brainomix 360 HyperdensityBrainomix Limited20260—
+1K250354Viz Subdural+, Viz SUBDURAL PLUSViz. Ai, Inc.20250—