Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

PZZ

Digital Pathology Display

Product code
PZZ
Device name
Digital Pathology Display
Device class
Class 2
21 CFR
21 CFR 864.3700
Medical specialty
Pathology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
3 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-05-23.

NumberDecision dateApplicantDevice nameSummary
K2425452025-05-23Eizo CorporationRadiForce MX317W-PAPDF
K2331192024-12-28Shenzhen Beacon Display Technology Co.…8MP Color LCD Displays C811W, C811WT, PA27 and PA27TPDF

2 summaries are archived here for direct download.

Official FDA classification page: PZZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).