510(k) Report

Devices descending from K113511

2 later devices reach Echostar Spica 1.5T MR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141945Echostar Comfort 1.5T MriAlltech Medical Systems America, Inc.20151—
+2K163192Comfort EC710Alltech Medical Systems America, Inc.20170—