Folliscan

Folliscan is a software application that analyzes transvaginal ultrasound images and video clips to automatically detect, count, and measure ovarian follicles. It is used as an aid to clinicians in interpreting ultrasound images during fertility treatment monitoring. Results must be manually verified using a DICOM viewer before clinical use.

Folliscan uses artificial intelligence-based algorithms with fixed (non-adaptive) machine learning to identify and measure follicles in both 2D and 3D ultrasound cine-loop data. It processes DICOM-formatted input from compatible ultrasound systems and can be accessed via web browser or programmatic API. The predicate device (Follicle Clarity) analyzes still ultrasound images rather than cine-loops, but both employ similar automatic segmentation technology to detect follicular structures.

Not stated in this summary.

Folliscan is substantially equivalent to the predicate device Follicle Clarity (K212012) because both are software applications designed to quantify image data from compatible ultrasound systems to measure follicle number and size. Both use machine learning-based algorithms for automatic structure identification and segmentation, share identical intended use and regulatory classification (Class II, 21 CFR 892.2050), and present no new safety or effectiveness concerns. Differences in input data type (cine-loop vs. still images) and algorithm implementation do not raise new questions of safety or effectiveness.