Koning Breast CT (KBCT) was approved by FDA PMA. The X-ray detector originally used in Koning Breast CT was PaxScan 4030CB. Recently, Koning Breast CT uses a modified X-ray detector PaxScan 4030MCT. The modified detector is essentially identical to the previous model except a different detector housing which allows a narrower dead-space between the active area and the top of the housing.~The benefit of the modified detector is that it allows Koning to modify the patient exam table, achieving a flatter surface in the center. The flatter surface will increase patient comfort and improve workflow.~Meanwhile, flatter surface may also affect patient positioning and the coverage of the breast. The adequacy of the overall image quality with the new table/detector should be verified by radiologists.~Images from ten (10) female patients (cases) with different breast sizes will be evaluated by 3 independent board-certified, MQSA-qualified radiologists (readers). The images were acquired from a separate clinical trial using KBCT system with the new table/detector.~Two readers will independently evaluate the image quality of each case and choose to accept or reject the case. If there is a disagreement for a certain case, a third reader will independently evaluate that case and give the final result.
Koning Breast CT (KBCT) was approved by FDA PMA. The X-ray detector originally used in Koning Breast CT was PaxScan 4030CB. Recently, Koning Breast CT uses a modified X-ray detector PaxScan 4030MCT. The modified detector is essentially identical to the previous model except a different detector housing which allows a narrower dead-space between the active area and the top of the housing.~The benefit of the modified detector is that it allows Koning to modify the patient exam table, achieving a flatter surface in the center. The flatter surface will increase patient comfort and improve workflow.~Meanwhile, flatter surface may also affect patient positioning and the coverage of the breast. The adequacy of the overall image quality with the new table/detector should be verified by radiologists.