510(k) Report

Devices descending from K183231

10 later devices reach SIGNA Premier through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193282SIGNA PremierGe Healthcare (Ge Medical Systems, LLC)202097
+2K253780SIGNA™ BoltGe Medical Systems, LLC20260—
+2K251399SIGNA™ SprintGe Medical Systems, LLC20251—
+2K241242Signa MagnusGe Medical Systems, LLC20240—
+2K213717AIR Recon DLGe Medical Systems,Llc (Ge Healthcare)20222—
+2K201615Signa 7.0TGe Medical Systems, LLC202011
+3K253808AIR Recon DLGE Medical Systems20260—
+3K253779SIGNA™ Sprint SelectGe Medical Systems, LLC20260—
+3K252379AIR Recon DLGe Medical Systems, LLC20250—
+3K211118Signa 7.0TGe Medical Systems, LLC202101