FDA-Device2013-09-04Class II
NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.
Nidek Inc
Hazard
Under certain circumstances, the Left eye image may be saved as the Right eye image.
Sold states
Nationwide US distribution only.
Affected count
86
Manufactured in
47651 Westinghouse Dr, Fremont, CA, United States
Products
NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2046-2013Don't want to check this manually?
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