FDA-Device2019-02-13Class II
GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and othe
GE Healthcare, LLC
Hazard
When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient selected on UV, which could result in an incorrect diagnosis.
Sold states
Worldwide Distribution: US (nationwide) in states of: AZ, CA, CO, DE, FL, IA, IL, IN, KS, MA, ME, MI, MN, MO, MS, MT, NE, NJ, NV, NY, OH, PA, PR, SC, SD, TN, TX, VA, VT, and WI; and countries of: Antigua, Australia, Austria, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Cote d'Ivoire, France, Germany, Guatemala, India, Italy, Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Panama, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
Affected count
297 (131 US; 166 OUS)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0793-2019Don't want to check this manually?
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