This device is classified as import for export, therefore 510k is not applicable.Model epk-i5010-us is available in the usa with a 510k number k182004.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the image noise.Based on the result, we concluded that it was caused due to the excessive shock applied on the video process device.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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