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.We checked the returned unit and confirmed that the ccd module blackout.Based on the result, we concluded that it was caused due to the physical damage applied on the ccd module.In addition, we confirmed that the insertion flexible tube (ift) fluid damage, the segment fluid damage, the control body fluid damage, the ccd driver pcb fluid damage, the electrical connector fluid damage, the lg cable connector fluid damage, the light guide cable buckled, the remote control button(1) cut, the remote control button(2) cut, the remote control button(3) cut, the remote control button(4) cut, the distal body worn out, the angulation-down angulation decrease, and the angulation-up angulation decrease; 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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