510(k) Report

Devices descending from K061952

5 later devices reach Cardiovascular Array Coils, Models Cac-63-16, Cac-63-32, Cac-123-32 and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212239XENOVIEW 3.0T Chest CoilPolarean, Inc.20222—
+1K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd.20190—
+1K120290Toshiba 1.5T Cardiac CoilQuality Electrodynamics20120—
+2K231647XENOVIEW 3.0T Chest CoilPolarean, Inc.20231—
+3K243316XENOVIEW 3.0T Chest CoilPolarean, Inc.20240—