510(k) Report

Devices descending from K951649

4 later devices reach Model #801GE1500 Pediatric Array Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1339861.5T Orbit and Mandible Array, 3.0T Orbit and Mandible ArrayResonance Innovations, LLC20141—
+1K0611703.0T Pediatric Head and Spine Array, Model 808GE3000Resonance Innovations, LLC20060—
+1K0606891.5T Pediatric Head and Spine Array ModelResonance Innovations, LLC20060—
+2K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd.20190—