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8 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Ge Healthcare Japan Corporation
Authorized purpose: True Definition DL is a deep-learning CT reconstruction function that enhances high-contrast spatial resolution for bone and lung imaging on compatible CT systems.
GE Healthcare Japan Corporation
Improve contrast of 120 kVp single-energy body CT images by estimating 50 keV GSI-like images as non-quantitative adjunct information for patients of all ages; the original 120 kVp image must remain available for interpretation.
GE Healthcare Japan Corporation
Authorized purpose: Deep Learning Image Reconstruction is a deep-learning reconstruction method that produces cross-sectional images of the head and whole body from X-ray transmission data acquired at different angles and planes, including axial, helical or volumetric, and cardiac acquisitions for all ages. It can be used for head, whole-body, cardiac, and vascular CT applications.
GE Healthcare Japan Corporation
TrueFidelity deep-learning CT reconstruction produces selectable-strength images for supported head, whole-body, cardiac, and vascular applications on the Discovery CT750 HD family.
GE Healthcare Japan Corporation
Authorized purpose: Revolution Ascend produces axial, cine, helical, cardiac, and gated CT images from X-ray transmission data with or without contrast, with post-processing and analysis for head, whole-body, cardiac, and vascular diagnosis, therapy planning, guidance, and monitoring.
GE Healthcare Japan Corporation
TrueFidelity deep-learning CT reconstruction produces selectable-strength images for supported head, whole-body, cardiac, and vascular applications on Revolution Ascend.
GE Healthcare Japan Corporation
Authorized purpose: Revolution Ascend is a diagnostic CT system for acquisition, reconstruction, display, and professional interpretation in the labeled scanner and protocol workflow.
GE Healthcare Japan Corporation
TrueFidelity deep-learning CT reconstruction produces selectable-strength images for supported head, whole-body, cardiac, and vascular applications on Revolution EVO.