510(k) Report

Devices descending from K052621

3 later devices reach 1.5T 16 Channel Brain-Spine Array Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113365Infant ArrayAdvanced Imaging Research Dba Sree Medical Systems20122—
+2K140998Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim CoilQuality Electrodynamics, LLC20141—
+3K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd.20190—