FDA-Device2019-07-31Class II
Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Merge Healthcare, Inc.
Hazard
Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).
Sold states
Nationwide distribution to Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Wisconsin. International distribution to Belgium and Canada.
Affected count
73 devices
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2063-2019Don't want to check this manually?
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