510(k) Report

Devices descending from K053017

6 later devices reach Models HRS-63-8 and HRS-127-8 Shoulder Array Coils through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1620011.5T and 3.0T 16 CH GE Shoulder CoilsInvivo Corporation201621
+1K071311Neocoil 1.5T 8-Channel Shoulder Array CoilNeocoil20072—
+2K232021Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TPhilips Healthcare (Suzhou) Co., Ltd.20231—
+2K071611Neocoil 3.0T 8-Channel Shoulder Array CoilNeocoil20071—
+3K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.20260—
+3K2011011.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder CoilNeocoil, LLC20200—