510(k) Report

Devices descending from K970573

4 later devices reach Flexart V3.5 Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080119ClearscanEsi, Inc.20080—
+1K983110Flexart,Flexart/Hyper, Visart, Visart/HyperToshiba America Mri, Inc.19992—
+2K993574Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc.20001—
+3K023207Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)Toshiba America Medical Systems, In.C20020—