This device is classified as import for export, therefore 510k is not applicable.Model eb-1575k is available in the usa with a 510k number k131028.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the ccd drive pcb as defective.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd drive pcb.In addition, our technician confirmed that the lg connector fluid damage, the light guide cable buckled, the lg prong top corroded, the lg connector corroded, the bending rubber cut, the remote control buttons cut, the biopsy inlet piece loose, and the electrical pin connector defective; 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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