FDA-Device2022-04-06Class II
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Diagnos Inc
Hazard
Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version.
Sold states
US: CA
Affected count
1
Manufactured in
7005 Taschereau Blvd Suite 265, N/A, Brossard, N/A, Canada
Products
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0826-2022Don't want to check this manually?
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