510(k) Report

Devices descending from K954190

11 later devices reach Model 580GE-64 Quadrature Abdominal Flex Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K0938421.5T and 3.0T General Purpose Flex CoilsInvivo Corporation20107—
+1K962117Quadrature and Phased Array Flexible Body CoilsPhilips Medical Systems (Cleveland), Inc.19962—
+2K122897Sense Head 16 Model 800647, Sense Spine 16 Model 800646; Sense Torso 16 Model 800645Invivo Corporation20123—
+2K1116731.5T and 3T 8-Channel Medium General Purpose Flex CoilInvivo Corporation20115—
+2K984588Phased Array Flexible Cardiac CoilPhilips Medical Systems (Cleveland), Inc.19991—
+3K212864dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TPhilips Healthcare (Suzhou) Co., Ltd.20212—
+3K14025216 CH Multipurpose Coil VarietyNoras Rontgen-Und Medizintechnik GmbH20140—
+3K120122Sense MSK S 8CH 1.5TInvivo Corporation20123—
+3K031095Sense Body CoilPhilips Medical Systems (Cleveland), Inc.20030—
+4K232021Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TPhilips Healthcare (Suzhou) Co., Ltd.20231—
+5K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.20260—