510(k) Report

Devices descending from K101295

7 later devices reach Mropen through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151466MrOpenParamed S.R.L.20153—
+1K123708Spine CoilUsa Paramed Medical Systems, Inc.20134—
+1K122034MRJ 3300Paramed S.R.L.20124—
+2K192690Upgrade Kit MR GUI PRO, MrJ 3300 PlusAsg Superconductors S.P.A.20190—
+2K190524MRopen 0.5 TAsg Superconductors S.P.A.20192—
+3K193116MRopen EVOAsg Superconductors S.P.A.20191—
+4K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)Asg Superconductors S.P.A.20240—