FDA-Device2016-08-10Class II
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Merge Healthcare, Inc.
Hazard
A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
Sold states
Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Jordan, New Zealand, and the United Kingdom.
Affected count
208 sites have the affected versions
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2303-2016Don't want to check this manually?
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