What Clinical Body Parts Should Be Included In Clinical Trials Of Medical X-ray Diagnostic Equipment ( Class M)?

Please refer to the “Guidance for product registration technical review of medical X-ray diagnostic equipment (Class III)”. Clinical parts usually include chest, abdomen, bone and soft tissue, gastrointestinal angiography, aortic angiography, organ angiography, and coronary angiography. The administrative counterparts shall select the applicable parts for clinical trial according to the intended use of the product.