510(k) Report

Devices descending from K160618

16 later devices reach Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163331Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T…Ge Medical Systems, LLC20171536
+2K202966SIGNA ArchitectGe Healthcare (Ge Medical Systems, LLC)202008
+2K202238SIGNA ArtistGe Healthcare (Tianjin) Company Limited202015
+2K171128SIGNA PremierGe Medical Systems, LLC2017118
+3K213603SIGNA Artist EvoGe Healthcare (Tianjin) Company Limited202201
+3K183231SIGNA PremierGe Medical Systems, LLC2019107
+4K193282SIGNA PremierGe Healthcare (Ge Medical Systems, LLC)202097
+5K253780SIGNA™ BoltGe Medical Systems, LLC20260—
+5K251399SIGNA™ SprintGe Medical Systems, LLC20251—
+5K241242Signa MagnusGe Medical Systems, LLC20240—
+5K213717AIR Recon DLGe Medical Systems,Llc (Ge Healthcare)20222—
+5K201615Signa 7.0TGe Medical Systems, LLC202011
+6K253808AIR Recon DLGE Medical Systems20260—
+6K253779SIGNA™ Sprint SelectGe Medical Systems, LLC20260—
+6K252379AIR Recon DLGe Medical Systems, LLC20250—
+6K211118Signa 7.0TGe Medical Systems, LLC202101