U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Camera, ophthalmic, ac-powered - Product Code HKI
원인
Image taken by afc-330 has a white spot which may affect diagnosis or evaluation of image.
조치
Field Correction notifications were sent to all affected users on June 16, 2014 by trackable method.
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.