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6 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Fujifilm Corporation
Authorized purpose: Concurrent-reader aid for a radiologist detecting pulmonary nodules during review of chest CT examinations in the lung cancer screening population under screening protocols.
Fujifilm Corporation
Authorized purpose: Fujifilm Synapse 3D Base Tools V7.2 provides trained professionals with two-dimensional, three-dimensional, multiplanar, and related viewing, measurement, and analysis functions for the supported DICOM studies.
Fujifilm Corporation
Authorized purpose: ECHELON Synergy is a whole-body MRI system that provides non-ionizing physiological and clinical information through transverse, coronal, sagittal, oblique, and curved cross-sectional images for trained physician interpretation.
FUJIFILM Corporation
Authorized purpose: Synapse 3D Base Tools assists trained professionals with reading, interpreting, reporting, and treatment planning from DICOM data from CT, MR, CR, US, NM, PT, XA, and other supported modalities; the base tools are not primary mammography interpretation.
FUJIFILM Corporation
Authorized purpose: SCENARIA View acquires axial, helical, dynamic, and interventional CT images of the body, including the head and whole body, supports reformats and volume rendering, and includes a low-dose lung-cancer-screening option used under established governmental or professional protocols.
Fujifilm Corporation
Authorized purpose: Synapse 3D Base Tools is medical-imaging software that provides trained medical professionals tools to aid reading, interpreting, reporting, and treatment planning. It accepts DICOM images from imaging devices including CT, MR, CR, US, NM, PT, and XA, and provides viewing, volume rendering, multiplanar reconstruction, fusion, subtraction, segmentation, measurements, annotations, reporting, image management, and modality-specific CT and MR tools. It is not intended for primary diagnostic interpretation of mammography images.