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 image distortion.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd module.In addition, we confirmed that the insertion flexible tube (ift) dented; however, it is 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.
|