FDA-Device2014-07-09Class II
Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.
Nidek Inc
Hazard
Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.
Sold states
Nationwide Distribution.
Affected count
185 cameras
Manufactured in
47651 Westinghouse Dr, Fremont, CA, United States
Products
Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1980-2014Don't want to check this manually?
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