510(k) Report

Devices descending from K162001

2 later devices reach 1.5T and 3.0T 16 CH GE Shoulder Coils through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232021Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TPhilips Healthcare (Suzhou) Co., Ltd.20231—
+2K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.20260—