GE Healthcare, LLC: When adding one or more intended scan groups names must contain only letters, numbers (0-9), or a space or the user interface will not update to confirm the intended group(s) has been added to the acquisition.

Agency Publication Date: July 8, 2021

Affected Products

Product: The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained

Revolution CT

Product: The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either withor without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a var

Revolution CT

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88208

Status: Active

Manufacturer: GE Healthcare, LLC

Manufactured In: United States

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Sources: FDA iRES · Raw API Response

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Affected Products

Revolution CT