FDA-Device2022-12-28Class II
Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.
GE Medical Systems, LLC
Hazard
There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.
Sold states
Nationwide distribution to CA, CO, DE, FL, IA, IL, MA, MI, MN, MO, MS, MT, ND, NJ, NY, OK, OR, SD, TX, WI, WV, WY. International distribution to Austria, Brazil, France, Germany, Ghana, Ireland, Italy, Kuwait, Poland, Saudi Arabia, South Africa, Spain, Switzerland, United Kingdom.
Affected count
1 unit
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging sources.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0721-2023Don't want to check this manually?
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