PGY
- Product code
- PGY
- Device name
- Display, Diagnostic Radiology
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.2050
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 17
- Summaries archived here
- 15 (direct download)
- 510(k) clearances (all years, FDA)
- 135 (all years; only the last 3 years are listed here)
FDA classification definition
The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.
510(k) clearances, last 3 years (17)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261213 | 2026-06-12 | Lg Electronics.Inc | Medical Monitor (40HT513D) | |
| K252780 | 2025-12-19 | Shenzhen Beacon Display Technology Co.… | LCD Monitor (CL1902A, CL2103F) | |
| K253242 | 2025-10-29 | Shenzhen Beacon Display Technology Co.… | LCD Monitor (C1216W, C822W, C821W) | |
| K252030 | 2025-08-28 | Eizo Corporation | RadiForce GX570; RadiForce GX570-AR | |
| K243221 | 2024-11-27 | Eizo Corporation | RadiForce RX570; RadiForce RX570-AR | FDA |
| K243031 | 2024-10-25 | Shenzhen Beacon Display Technology Co.… | LCD Monitors C310S, G310S, C316S, G316S, C616W | |
| K242008 | 2024-08-02 | Barco N.V. | Coronis OneLook | |
| K241105 | 2024-08-01 | Jvckenwood Corporation | 3MP Color LCD Monitor (CL-S301) | |
| K241441 | 2024-07-16 | Eizo Corporation | RadiForce RX670; RadiForce RX670-AR | |
| K241499 | 2024-06-13 | Acula Technology Corp. | 21.3 5MP Color LCD Display UMD5-21B01 | |
| K233336 | 2024-05-21 | Acula Technology Corp. | 21.3 3MP Color LCD Display UMD3-21B01 (MD3-21B01) | |
| K240310 | 2024-03-29 | Shenzhen Beacon Display Technology Co.… | LCD Monitors C310S, G310S, C316S, G316S, C616W | |
| K240130 | 2024-02-15 | Lg Electronics.Inc | Medical Monitor (21HQ613D) | FDA |
| K233897 | 2024-02-06 | Shenzhen Beacon Display Technology Co.… | 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors … | |
| K233465 | 2023-12-21 | Eizo Corporation | RadiForce MX317W | |
| K233693 | 2023-12-11 | Barco N.V. | Nio Color 8MP (MDNC-8132) | |
| K232985 | 2023-12-11 | Lg Electronics.Inc | 24HR513C |
Official FDA classification page: PGY
Classification and pathway per current FDA publications. Data from openFDA (CC0).