510(k) Report

Devices descending from K981475

7 later devices reach Opart (MRT-600) Versions 2 Software Upgrade through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990260OPARTToshiba America Mri, Inc.19996—
+2K151466MrOpenParamed S.R.L.20153—
+2K993574Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc.20001—
+3K190524MRopen 0.5 TAsg Superconductors S.P.A.20192—
+3K023207Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)Toshiba America Medical Systems, In.C20020—
+4K193116MRopen EVOAsg Superconductors S.P.A.20191—
+5K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A.20240—