510(k) Report

Devices descending from K113365

2 later devices reach Infant Array through their predicates, nearest generation first.

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