FDA-Device2016-09-07Class II
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
Merge Healthcare, Inc.
Hazard
Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
Sold states
US Distribution to: CO and OK.
Affected count
96 sites potentially have the affected versions for both products
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2685-2016Don't want to check this manually?
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