510(k) Report

Devices descending from K063513

8 later devices reach Echelon MR-RCC-150 Cardiac Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110120Echelon Rapid Cardiac CoilHitachi Medical Systems America, Inc.20110—
+1K081340Pediatric Body and Cardiac Coil, Model 01000140201Shanghai Chenguang Medical Technologies Co, Ltd.20086—
+2K101949Pediatric Body-Cardiac Coil, Model: 5000012601Shanghai Chenguang Medical Technologies Co, Ltd.20105—
+3K213397InkSpace Imaging Pediatric Body ArrayInkspace Imaging, Inc.20214—
+4K223487InkSpace Imaging Body ArrayInkspace Imaging, Inc.20223—
+5K233444InkSpace Imaging Small Body ArrayInkspace Imaging, Inc.20242—
+6K253182InkSpace Imaging Small Body Array (SBA12PH30x)Inkspace Imaging, Inc.20250—
+6K243675InkSpace Imaging Small Body ArrayInkspace Imaging, Inc.20240—