510(k) Report

Devices descending from K193282

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

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