DeviceClearance

Product code PZZ— Pathology

8MP Color LCD Displays C811W, C811WT, PA27 and PA27T

Classification name
Digital Pathology Display
Device class
Class 2
Regulation
21 CFR 864.3700
Advisory panel
Pathology
Total cleared
3
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code PZZ under 21 CFR 864.3700, via openFDA

Market context for product code PZZ

FDA has cleared 3 devices under product code PZZ between 2017 and 2025, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PZZ

Recent clearances under product code PZZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.