FDA-Device2019-07-03Class II
Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: 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 interpretat
GE Healthcare, LLC
Hazard
There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
Sold states
Worldwide Distribution - US Nationwide Austria, Belgium, Brazil Canada Colombia France Germany Ghana India Ireland Israel Italy Kuwait Mexico Netherlands Panama Poland Qatar Russia Saudi Arabia Slovenia South Africa Spain Switzerland Turkey United Arab Emirates United Kingdom Uruguay
Affected count
50 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: 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. Mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies. Contraindications: Centricity Universal Viewer is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1885-2019Don't want to check this manually?
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