FDA-Device2019-07-10Class II
Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.
GE Healthcare, LLC
Hazard
There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.
Sold states
Worldwide Distribution: US (nationwide) to states of: FL, GA, IL, IN, LA, MA, MO, NJ, NY, OR, PA, SC, SD, TX, and WA; and countries of : Brazil, Canada, Chile, France, French Polynesia, Germany, India, Italy, Japan, Kuwait, Lebanon, Singapore, Spain and United Kingdom.
Affected count
92 (47 US 103 OUS)
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1911-2019Don't want to check this manually?
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