FDA product code PGY: Display, Diagnostic Radiology
PGY is the FDA product code for display, diagnostic radiology. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Radiology panel. FDA has cleared 136 510(k) submissions under PGY, 42 in the last five years, from 19 different applicants. The average 510(k) review took 61 days (median 50); 58 days on average over the last three years. FDA has posted 6 recalls for PGY devices.
Definition
The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.
Classification
| Field | Value |
|---|---|
| Device name | Display, Diagnostic Radiology |
| Device class | Class II |
| Regulation | 21 CFR 892.2050 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PGY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 11 | 34 |
| 2018 | 5 | 46 |
| 2019 | 11 | 71 |
| 2020 | 12 | 86 |
| 2021 | 7 | 93 |
| 2022 | 10 | 87 |
| 2023 | 17 | 83 |
| 2024 | 10 | 65 |
| 2025 | 3 | 66 |
| 2026 | 2 | 42 |
Compare with all 510(k) review times · Search every PGY clearance
Top PGY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eizo Corporation | 26 | 2026-09-01 |
| Nanjing Jusha Display Technology Co., Ltd. | 22 | 2023-06-09 |
| Jvckenwood Corporation | 16 | 2024-08-01 |
| Wide Corporation | 14 | 2023-05-09 |
| Shenzhen Beacon Display Technology Co., Ltd. | 13 | 2025-12-19 |
14 more applicants have PGY clearances. See the full list in Caduvo.
Most recent PGY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262783 | Eizo Corporation | RadiForce MX247W | 2026-09-01 | 26 |
| K261213 | Lg Electronics.Inc | Medical Monitor (40HT513D) | 2026-06-12 | 59 |
| K252780 | Shenzhen Beacon Display Technology Co., Ltd. | LCD Monitor (CL1902A, CL2103F) | 2025-12-19 | 108 |
| K253242 | Shenzhen Beacon Display Technology Co., Ltd. | LCD Monitor (C1216W, C822W, C821W) | 2025-10-29 | 30 |
| K252030 | Eizo Corporation | RadiForce GX570; RadiForce GX570-AR | 2025-08-28 | 59 |
Recalls for PGY devices
6 product recalls in 3 recall events; 0 initiated in the last five years and 2 still open. Most recent: 2021-01-22.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code PGY?
PGY is the FDA product code for display, diagnostic radiology. It is a Class II device, regulated under 21 CFR 892.2050 and reviewed by the Radiology panel.
What device class is PGY?
Class II, regulation 21 CFR 892.2050. Typical premarket route: 510(k).
How long does a 510(k) take for product code PGY?
Across 136 cleared submissions the average was 61 days from receipt to decision (median 50).
Which companies have the most PGY clearances?
Eizo Corporation (26); Nanjing Jusha Display Technology Co., Ltd. (22); Jvckenwood Corporation (16); Wide Corporation (14); Shenzhen Beacon Display Technology Co., Ltd. (13).
Have PGY devices been recalled?
Yes: 6 product recalls across 3 recall events; the most recent began 2021-01-22.
Next steps
- Run an FDA pathway report with predicate devices for product code PGY
- Run a recall and safety report across every PGY manufacturer
- Watch product code PGY 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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