FDA Product Code PZZ: Digital Pathology Display
The Digital Pathology Display Device Is Intended For In Vitro Diagnostic Use To Display Digital Images Of Histopathology Slides Acquired From Fda-cleared Whole-slide Imaging Scanners That Are Used For Review And Interpretation By Trained Pathologists.
Leading manufacturers include Barco N.V., Shenzhen Beacon Display Technology Co., Ltd. and Eizo Corporation.
FDA 510(k) Cleared Digital Pathology Display Devices (Product Code PZZ)
About Product Code PZZ - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code PZZ since 2017, with 3 receiving FDA clearance (average review time: 271 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PZZ have taken an average of 364 days to reach a decision - up from 87 days historically. Manufacturers should account for longer review timelines in current project planning.
PZZ devices are reviewed by the Pathology panel. Browse all Pathology devices →