510(k) Report

Devices descending from K133705

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213465CardioGrapheArineta, Ltd.20223—
+1K163213Revolution CTGe Medical Systems, LLC20161516
+1K161066SpotLight CTArineta, Ltd.20164—
+2K230370SpotLight/SpotLight Duo (with DLIR option)Arineta, Ltd.20232—
+2K191777Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex editionGe Medical Systems, LLC2019518
+2K183202Deep Learning Image ReconstructionGe Medical Systems, LLC20198—
+3K241200SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta, Ltd.20251—
+3K220961Deep Learning Image ReconstructionGe Healthcare Japan Corporation20220—
+3K213999Deep Learning Image ReconstructionGe Medical Systems, LLC20222—
+3K213715Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex…Ge Medical Systems, LLC2021411
+3K201745Deep Learning Image Reconstruction for Gemstone Spectral ImagingGe Medical Systems, LLC20200—
+3K193073Deep ReconShanghai United Imaging Healthcare Co., Ltd.20200—
+3K193170Deep Learning Image ReconstructionGe Healthcare Japan Corporation20191—
+4K253560Enhanced Boundary for PCCTGe Medical Systems, LLC20260—
+4K253686True Definition DLGe Healthcare Japan Corporation20260—
+4K253520Photonova Spectra, Photonova Spectra SelectGe Medical Systems, LLC20260—
+4K250941Revolution VibeGe Medical Systems, LLC20250—
+4K250650SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta, Ltd.20250—
+4K233750ECG-less CardiacGe Medical Systems, LLC20240—
+4K230807Deep Learning Image ReconstructionGe Healthcare Japan Corporation20230—
+4K212067Deep Learning Image ReconstructionGe Healthcare Japan Corporation20210—