FDA 510(k) Clearance

MySegmenter has received FDA 510(k) clearance as a Medical Image Management and Processing System under 21 CFR 892.2050. This clearance confirms that MySegmenter is substantially equivalent to legally marketed predicate devices for the indicated uses.

Regulation Name: Medical Image Management And Processing System

Intended Use: MySegmenter is intended for use in medical image segmentation and 3D visualization of CT and MRI data by trained healthcare professionals.

For questions about this clearance or our regulatory compliance, please contact us.