Software for diagnosing cancer is a Class II medical device

The software for diagnosing cancer is a Class II medical device. Class II medical device refers to the use of medical technology, the human body for the prevention, diagnosis, treatment, orthopedic or relief of disease, injury or disability of the device, its safety and effectiveness need to be strictly controlled and regulated. Class II medical devices are the most representative medical devices, involving a wide range of categories, which can be divided into the following categories: diagnostic devices, therapeutic devices, surgical devices, implantable devices, in vitro diagnostic reagents, supportive devices, dental devices and other devices. Diagnostic cancer software belongs to the diagnostic class of devices, belonging to the second class of medical devices.