510(k) Report

Devices descending from K171128

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183231SIGNA PremierGe Medical Systems, LLC2019107
+2K193282SIGNA PremierGe Healthcare (Ge Medical Systems, LLC)202097
+3K253780SIGNA™ BoltGe Medical Systems, LLC20260—
+3K251399SIGNA™ SprintGe Medical Systems, LLC20251—
+3K241242Signa MagnusGe Medical Systems, LLC20240—
+3K213717AIR Recon DLGe Medical Systems,Llc (Ge Healthcare)20222—
+3K201615Signa 7.0TGe Medical Systems, LLC202011
+4K253808AIR Recon DLGE Medical Systems20260—
+4K253779SIGNA™ Sprint SelectGe Medical Systems, LLC20260—
+4K252379AIR Recon DLGe Medical Systems, LLC20250—
+4K211118Signa 7.0TGe Medical Systems, LLC202101