This device is classified as import for export, therefore 510k is not applicable.Model fnl-7rp3 is available in the usa with a 510k number k951196.We checked the returned unit and confirmed that the objective lens unit cloudy (not clear view).Based on the result, we concluded that it was caused due to the moisture condensation in the objective lens unit.In addition, we confirmed that the biopsy inlet piece missing, and the forward body cover worn out; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0586(image failure)"" and/or the risk analysis results, it was evaluated to submit mdr.
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