This device is classified as import for export, therefore 510k is not applicable.Model eg29-i10c-us is available in the usa with a 510k number k190805.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the cmos module with drive pcb shadow in image.Based on the result, we concluded that it was caused due to the moisture condensation in the cmos module with drive pcb.In addition, our technician confirmed that the insertion flexible tube buckled, the lg connector corroded, the brand plate missing, the remote control buttons cut, the segment steel braid rupture, the led cover glass signs of moisture or fluid under and the cover glass; however, these defects 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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