This document applies to software for 2D x ray image analysis in dental medicine, the basis of which is the application of artificial intelligence (AI).
The scope of applicability of this document includes
a) Software-as-a-Medical Device (SaMD)
b) Software-in-a-Medical Device (SiMD) and
c) Software to improve the efficiency of healthcare applications.
This document applies to AI applications that learn statically and continuously/incrementally.
IN_DEVELOPMENT
prEN ISO 18374
45.99
Dispatch of FV draft to CCMC
Dec 6, 2024