510(k) Report

Devices descending from K163205

3 later devices reach 48CH Head 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—
+1K18066648CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20181—
+2K2537383.0T Air 32CH HnaGe Healthcare Coils (Usa Instruments, Inc.)20260—