510(k) Report

Devices descending from K060758

4 later devices reach OR Head Coil 1.5 T through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110411Atama SystemMonteris Medical, Inc.20111—
+1K091546Noras or Head Coil 3T, Models SI7200/SI72100/SI7220/SI7230Noras Mri Products GmbH20091—
+2K190668Encompass 15 Channel Head Coil, 3TQfix20190—
+2K132444Atama SystemMonteris Medical,20140—