510(k) Report

Devices descending from K163213

15 later devices reach Revolution CT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191777Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex editionGe Medical Systems, LLC2019518
+1K183202Deep Learning Image ReconstructionGe Medical Systems, LLC20198—
+2K220961Deep Learning Image ReconstructionGe Healthcare Japan Corporation20220—
+2K213999Deep Learning Image ReconstructionGe Medical Systems, LLC20222—
+2K213715Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex…Ge Medical Systems, LLC2021411
+2K201745Deep Learning Image Reconstruction for Gemstone Spectral ImagingGe Medical Systems, LLC20200—
+2K193073Deep ReconShanghai United Imaging Healthcare Co., Ltd.20200—
+2K193170Deep Learning Image ReconstructionGe Healthcare Japan Corporation20191—
+3K253560Enhanced Boundary for PCCTGe Medical Systems, LLC20260—
+3K253686True Definition DLGe Healthcare Japan Corporation20260—
+3K253520Photonova Spectra, Photonova Spectra SelectGe Medical Systems, LLC20260—
+3K250941Revolution VibeGe Medical Systems, LLC20250—
+3K233750ECG-less CardiacGe Medical Systems, LLC20240—
+3K230807Deep Learning Image ReconstructionGe Healthcare Japan Corporation20230—
+3K212067Deep Learning Image ReconstructionGe Healthcare Japan Corporation20210—