510(k) Report

Devices descending from K052585

8 later devices reach 3T HD Breast Array through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1733773.0T 16ch Breast CoilNeocoil, LLC20173—
+1K070778Neocoil 3.0T 6-Channel Carotid Array CoilNeocoil20070—
+1K061715Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc.20062—
+2K22240716ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T…Neocoil, LLC20221—
+2K1829581.5T 16ch Breast CoilNeocoil, LLC20182—
+2K083434TT1 General Purpose CoilTursiop Technologies, LLC20081—
+3K2609470.55T 12Ch Breast CoilNeocoil, LLC20260—
+3K113280Carotid Coil GE 1.5TTursiop Technologies, LLC20110—