510(k) Report

Devices descending from K081105

35 later devices reach GE Lightspeed CT750 HD (Lightspeed 8.0) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120833Discovery CT750 HDGe Medical Systems, LLC2012281
+1K103489GE Veo Reconstruction OptionGeneral Electric Co.201110—
+1K090462Brilliance Dual Energy OptionPhilips Medical Systems (Cleveland), Inc.20093—
+2K133705Revolution CTGe Medical Systems, LLC20142114
+2K133640ASIR-VGe Medical Systems, LLC20149—
+2K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+2K121827Gsi Viewer with Vue OptionGE Medical Systems SCS20122—
+2K0937033DIShina Systems, Ltd.20102—
+3K223514Spectral Bone MarrowGe Medical Systems, LLC20230—
+3K213465CardioGrapheArineta, Ltd.20223—
+3K183202Deep Learning Image ReconstructionGe Medical Systems, LLC20198—
+3K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+3K180225GSI Viewer with GSI Fat OptionGE Medical Systems SCS20180—
+3K163213Revolution CTGe Medical Systems, LLC20161516
+3K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+3K161066SpotLight CTArineta, Ltd.20164—
+3K1125303DI Including CscoreShina Systems, Ltd.20111—
+4K230370SpotLight/SpotLight Duo (with DLIR option)Arineta, Ltd.20232—
+4K220961Deep Learning Image ReconstructionGe Healthcare Japan Corporation20220—
+4K213999Deep Learning Image ReconstructionGe Medical Systems, LLC20222—
+4K201745Deep Learning Image Reconstruction for Gemstone Spectral ImagingGe Medical Systems, LLC20200—
+4K193073Deep ReconShanghai United Imaging Healthcare Co., Ltd.20200—
+4K193170Deep Learning Image ReconstructionGe Healthcare Japan Corporation20191—
+4K191777Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex editionGe Medical Systems, LLC2019518
+4K1134423DIShina Systems, Ltd.20120—
+5K253686True Definition DLGe Healthcare Japan Corporation20260—
+5K241200SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta, Ltd.20251—
+5K230807Deep Learning Image ReconstructionGe Healthcare Japan Corporation20230—
+5K213715Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex…Ge Medical Systems, LLC2021411
+5K212067Deep Learning Image ReconstructionGe Healthcare Japan Corporation20210—
+6K253560Enhanced Boundary for PCCTGe Medical Systems, LLC20260—
+6K253520Photonova Spectra, Photonova Spectra SelectGe Medical Systems, LLC20260—
+6K250941Revolution VibeGe Medical Systems, LLC20250—
+6K250650SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening OptionArineta, Ltd.20250—
+6K233750ECG-less CardiacGe Medical Systems, LLC20240—