510(k) Report

Devices descending from K221100

4 later devices reach Viz RV/LV through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230534BriefCase-QuantificationAidoc Medical, Ltd.20233—
+2K243779Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health20250—
+2K241112BriefCase-QuantificationAidoc Medical, Ltd.20241—
+3K242203BriefCase-QuantificationAidoc Medical, Ltd.20240—