This device is classified as import for export, therefore 510k is not applicable.Model vnl11-j10 is available in the usa with a 510k number k172156.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the ccd module with drive pcb as defective.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd module with drive pcb.In addition, our technician confirmed that the control body corroded, the remote control buttons cut, the electrical pin connector dirty, the segment worn out, the insertion flexible tube dented, and the ccd module with drive pcb distorted image; however, these defects are 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.
|