510(k) Report

Devices descending from K012200

103 later devices reach 1.5T Infinity Twinspeed MR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+15K253779SIGNA™ Sprint SelectGe Medical Systems, LLC20260—
+15K252379AIR Recon DLGe Medical Systems, LLC20250—
+15K211118Signa 7.0TGe Medical Systems, LLC202101