This device is not distributed in us so that 510k# is blank.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 excessive force applied on the ccd module.In addition, we confirmed that the root brace rubber cracked; 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.
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