510(k) Report

Devices descending from K121517

9 later devices reach Versavue Enterprise Suite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192200DynaCADInvivo Corporation20196—
+1K173744ProFuse CADEigen20181—
+2K212175DynaCADInvivo Corporation20210—
+2K193306PROViewGE Medical Systems SCS20200—
+2K202501Quantib ProstateQuantib B.V.20203—
+2K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+3K233196Medihub ProstateJLK, Inc.20240—
+3K221106Quantib ProstateQuantib B.V.20221—
+4K230772Quantib ProstateQuantib B.V.20230—