FDA Product Code MYN: Analyzer, Medical Image

Under FDA product code MYN, medical image analyzers are cleared for the quantitative analysis of radiological images.

These software systems perform automated measurements, segmentation, and quantification of structures visible in medical images — including organ volumes, lesion sizes, and tissue densities — providing reproducible quantitative data to supplement visual interpretation.

MYN devices are Class II medical devices, regulated under 21 CFR 892.2070 and reviewed by the FDA Radiology panel.

Leading manufacturers include Pearl, Inc., Overjet, Inc. and Imagen Technologies, Inc..