FDA product code PZZ: Digital Pathology Display
PZZ is the FDA product code for digital pathology display. It is a Class II device, regulated under 21 CFR 864.3700 and reviewed by the Pathology panel. FDA has cleared 3 510(k) submissions under PZZ, 2 in the last five years, from 3 different applicants. The average 510(k) review took 271 days (median 269); 364 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Digital Pathology Display |
| Device class | Class II |
| Regulation | 21 CFR 864.3700 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PZZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 87 |
| 2024 | 1 | 458 |
| 2025 | 1 | 269 |
Compare with all 510(k) review times · Search every PZZ clearance
Top PZZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eizo Corporation | 1 | 2025-05-23 |
| Shenzhen Beacon Display Technology Co., Ltd. | 1 | 2024-12-28 |
| Barco N.V. | 1 | 2017-12-21 |
Most recent PZZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242545 | Eizo Corporation | RadiForce MX317W-PA | 2025-05-23 | 269 |
| K233119 | Shenzhen Beacon Display Technology Co., Ltd. | 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T | 2024-12-28 | 458 |
| K172922 | Barco N.V. | MMPC-4127F1 | 2017-12-21 | 87 |
Recalls for PZZ devices
openFDA lists no recalls for product code PZZ.
Frequently asked questions
What is FDA product code PZZ?
PZZ is the FDA product code for digital pathology display. It is a Class II device, regulated under 21 CFR 864.3700 and reviewed by the Pathology panel.
What device class is PZZ?
Class II, regulation 21 CFR 864.3700. Typical premarket route: 510(k).
How long does a 510(k) take for product code PZZ?
Across 3 cleared submissions the average was 271 days from receipt to decision (median 269).
Which companies have the most PZZ clearances?
Eizo Corporation (1); Shenzhen Beacon Display Technology Co., Ltd. (1); Barco N.V. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PZZ
- Run a recall and safety report across every PZZ manufacturer
- Watch product code PZZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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