510(k) Report

Devices descending from K010946

4 later devices reach Mark 9000 Phased Array Shoulder Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042009Mark Iii Phased Array Shoulder CoilUsa Instruments, Inc.20042—
+1K020268Isaac 1.5 T MR SystemChi, Inc.20020—
+2K071611Neocoil 3.0T 8-Channel Shoulder Array CoilNeocoil20071—
+3K2011011.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder CoilNeocoil, LLC20200—