Software core algorithm refers to the algorithm necessary to realize the software core function (the function necessary for the software to complete the intended use in the intended environment), including but not limited to imaging algorithm, post-processing algorithm and artificial intelligence algorithm.
Even if there is no post-processing algorithm for medical images or data, if the device uses relevant software algorithms to achieve its intended clinical use (such as energy output control algorithm for therapeutic devices), it is also considered into the scope of core algorithms.
Sources: NMPA
