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 ccd drive pcb fluid damage.Based on the result, we concluded that it was caused due to the fluid damage from the ccd drive pcb.In addition, our technician confirmed that the control body fluid damage, the down pulley wire fluid damage, the up pulley wire fluid damage, the left pulley wire fluid damage, the right pulley wire fluid damage, the mechanical base plate fluid damage, the electrical pin connector fluid damage, the lg connector fluid damage, the objective lens broken, the objective lens cracked, the cmos module with drive pcb objective lens cracked, the operation channel (primary) leak, and the side body cover leak; 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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