This device is classified as import for export, therefore 510k is not applicable.Model eg29-i10c-us is available in the usa with a 510k number k190805.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the image cloudy (not clear view).Based on the result, we concluded that it was caused due to the moisture condensation in the cmos module.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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