510(k) Report

Devices descending from K050514

8 later devices reach Models Fac-63 and Fac-127 Foot and Ankle Coils through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242096dS FootAnkle Coil 8ch 1.5TPhilips Medical Systems Nederland B.V.20240—
+1K162177dS FootAnkle I6CH 1.5T CoilInvivo Corporation20162—
+1K1516538ch Foot Ankle CoilShenzhen RF Tech Co., Ltd.20151—
+1K122694GE 8CH Foot Ankle CoilGe Hangwei Medical Systems Co., Ltd.20121—
+2K213766dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and…Invivo Corporation20211—
+2K1609328ch Foot Ankle CoilShenzhen RF Tech Co., Ltd.20160—
+2K1609358ch Foot Ankle CoilShenzhen RF Tech Co., Ltd.20160—
+3K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes…Philips Medical Systems Nederland B.V.20260—