510(k) Report

Devices descending from K111673

5 later devices reach 1.5T and 3T 8-Channel Medium General Purpose Flex Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212864dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TPhilips Healthcare (Suzhou) Co., Ltd.20212—
+1K14025216 CH Multipurpose Coil VarietyNoras Rontgen-Und Medizintechnik GmbH20140—
+1K120122Sense MSK S 8CH 1.5TInvivo Corporation20123—
+2K232021Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TPhilips Healthcare (Suzhou) Co., Ltd.20231—
+3K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.20260—