PZZ
- 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)
- 3
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.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K242545 | 2025-05-23 | Eizo Corporation | RadiForce MX317W-PA summary |
| K233119 | 2024-12-28 | Shenzhen Beacon Display Technology Co. | 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T summary |
Official FDA classification page: PZZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).