510(k) Report

Devices descending from K012495

7 later devices reach OR Table and Headholder/Magnetom Harmony, Symphony, Sonata Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071179Noras or Head HolderSiemens Medical Solutions USA, Inc.20076—
+2K133506Noras or Head Holder FlexibilityNoras Mri Products GmbH20141—
+2K110411Atama SystemMonteris Medical, Inc.20111—
+2K091439Head Fixation Arc and Table BaseSurgivision, Inc.20091—
+3K211658OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet…Noras Mri Products GmbH20220—
+3K191701Arcus Head Fixation FrameMri Interventions, Inc.20190—
+3K132444Atama SystemMonteris Medical,20140—