This device is classified as import for export, therefore 510k is not applicable.Model eb-1570k 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 video image distortion.Based on the result, we concluded that it was caused due to the excessive force applied on the fiber.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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