510(k) Report

Devices descending from K140998

1 later device reach Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd.20190—