FDA-Device2013-06-12Class III
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Optovue, Inc.
Hazard
Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports.
Sold states
Distributed Nationwide and in Canada.
Affected count
~329 users
Manufactured in
2800 Bayview Dr, N/A, Fremont, CA, United States
Products
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1441-2013Don't want to check this manually?
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