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 cmos module with drive pcb fluid damage.Based on the result, we concluded that it was caused due to the fluid damage from the cmos module with drive pcb.In addition, our technician confirmed that the bending rubber leak; however, this defect 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.
|