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 module with drive pcb out of focus.Based on the result, we concluded that it was caused due to the moisture condensation on the ccd module with drive pcb.In addition, our technician confirmed that the electrical pin connector fluid damage, the lg prong top corroded, the lg connector corroded, the lcb (light carrying bundle) crushed, the remote control buttons cut; 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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