510(k) Report

Devices descending from K003613

108 later devices reach 3.0.T Signa VH/I (T/R) Body Imaging Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+15K251399SIGNA™ SprintGe Medical Systems, LLC20251—
+15K241242Signa MagnusGe Medical Systems, LLC20240—
+15K213717AIR Recon DLGe Medical Systems,Llc (Ge Healthcare)20222—
+15K201615Signa 7.0TGe Medical Systems, LLC202011
+16K253808AIR Recon DLGE Medical Systems20260—
+16K253779SIGNA™ Sprint SelectGe Medical Systems, LLC20260—
+16K252379AIR Recon DLGe Medical Systems, LLC20250—
+16K211118Signa 7.0TGe Medical Systems, LLC202101