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., Ventana Medical Systems, Inc. and Barco N.V..
FDA 510(k) Cleared Whole Slide Imaging System Devices (Product Code PSY)
About Product Code PSY - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code PSY since 2017, with 18 receiving FDA clearance (average review time: 180 days).
Submission volume has remained relatively stable over the observed period, with 7 submissions in the last 24 months.
FDA Review Time
FDA review times for PSY submissions have been consistent, averaging 173 days recently vs 184 days historically.
PSY devices are reviewed by the Pathology panel. Browse all Pathology devices →