FDA Product Code PSY: Whole Slide Imaging System

Digital pathology is transforming how tissue diagnoses are made and shared. FDA product code PSY covers whole slide imaging systems used in pathology.

These automated digital scanners capture high-resolution images of entire histology slides, enabling pathologists to review, annotate, and share cases remotely. WSI systems are also the foundation for AI-assisted pathology algorithms that detect and quantify tumor features.

PSY devices are Class II medical devices, regulated under 21 CFR 864.3700 and reviewed by the FDA Pathology panel.

Leading manufacturers include Philips Medical Systems Nederland B.V., Leica Biosystems Imaging, Inc. and Hamamatsu Photonics K.K..