510(k) Report

Devices descending from K060052

13 later devices reach GE Lightspeed Xtra CT Scanner System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082104GE Lightspeed RT16 / Lightspeed Xtra V2 CT System (Aka GE Lightspeed RT16 / Lightspeed…Ge Medical Systems, Inc.2008121
+2K093581Discovery Model CT590 RT and Optima Model CT580 CT SystemsGe Medical Systems, LLC2011114
+3K133640ASIR-VGe Medical Systems, LLC20149—
+3K132410Discovery CT 590 RT, Optima CT 580, Optima CT 580 RT, Optima CT 580 WGe Medical Systems, LLC201402
+4K183202Deep Learning Image ReconstructionGe Medical Systems, LLC20198—
+5K220961Deep Learning Image ReconstructionGe Healthcare Japan Corporation20220—
+5K213999Deep Learning Image ReconstructionGe Medical Systems, LLC20222—
+5K201745Deep Learning Image Reconstruction for Gemstone Spectral ImagingGe Medical Systems, LLC20200—
+5K193073Deep ReconShanghai United Imaging Healthcare Co., Ltd.20200—
+5K193170Deep Learning Image ReconstructionGe Healthcare Japan Corporation20191—
+6K253686True Definition DLGe Healthcare Japan Corporation20260—
+6K230807Deep Learning Image ReconstructionGe Healthcare Japan Corporation20230—
+6K212067Deep Learning Image ReconstructionGe Healthcare Japan Corporation20210—