FDA-Device2018-06-13Class II

Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be in

GE Healthcare
Hazard

Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.

Sold states
Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, LA, MA, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OK, OR. PA. SD, TN, TX, UT, WA, WI, WV, and WY and the countries of Austria, Belgium, Brazil, Canada, Colombia, France, Germany, Ghana, India, Ireland, Israel, Italy, Kuwait, Malaysia, Mexico, Netherlands, Panama, Poland, Russia, Saudi Arabia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, United Kingdomand Uruguay
Affected count
252
Manufactured in
500 W Monroe St, N/A, Chicago, IL, United States
Products
Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2102-2018

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