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 objective lens was broken.Based on the result, we concluded that it was caused due to the excessive force applied on the objective lens.In addition, our technician confirmed that the lcb distal cover glass broken, the light guide cable crushed, the remote control button(3) leak, and the distal body worn out; however, they 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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