510(k) Report

Devices descending from K013159

12 later devices reach HRH-63-8 Head Array Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110591MC 1504G-16R, 1.5T, 16-Channel, MC 3004G-16R, 3.0T, 16-Channel Head CoilMr Instruments, Inc.20110—
+1K091546Noras or Head Coil 3T, Models SI7200/SI72100/SI7220/SI7230Noras Mri Products GmbH20091—
+1K060758OR Head Coil 1.5 TSiemens Medical Solutions USA, Inc.20064—
+1K0226698 Channel Cardiac Phased Array CoilGE Medical Systems20025—
+2K190668Encompass 15 Channel Head Coil, 3TQfix20190—
+2K110411Atama SystemMonteris Medical, Inc.20111—
+2K0320458 Channel Cardiac Phased Array CoilGE Medical Systems20031—
+2K031209GE 1.5T 8 Channel Torso CoilGe Medical Systems, Inc.20033—
+3K132444Atama SystemMonteris Medical,20140—
+3K1014928 Channel Cardiac Phased Array CoilGe Healthcare Coils (Usa Instruments, Inc.)20100—
+3K073236Neocoil 3.0T 32-Channel Torso Array Coil for GENeocoil20070—
+3K0525841.5T 12 Channel Body ArrayUsa Instruments, Inc.20051—