PGY
- 产品代码
- PGY
- 器械名称
- Display, Diagnostic Radiology
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 892.2050
- FDA 专业组
- Radiology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 135 件
FDA 分类定义
The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.
该代码近三年的 510(k)（17 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K261213 | 2026-06-12 | Lg Electronics.Inc | Medical Monitor (40HT513D) 摘要 |
| K252780 | 2025-12-19 | Shenzhen Beacon Display Technology Co. | LCD Monitor (CL1902A, CL2103F) 摘要 |
| K253242 | 2025-10-29 | Shenzhen Beacon Display Technology Co. | LCD Monitor (C1216W, C822W, C821W) 摘要 |
| K252030 | 2025-08-28 | Eizo Corporation | RadiForce GX570; RadiForce GX570-AR 摘要 |
| K243221 | 2024-11-27 | Eizo Corporation | RadiForce RX570; RadiForce RX570-AR 摘要 |
| K243031 | 2024-10-25 | Shenzhen Beacon Display Technology Co. | LCD Monitors C310S, G310S, C316S, G316S, C616W 摘要 |
| K242008 | 2024-08-02 | Barco N.V. | Coronis OneLook 摘要 |
| K241105 | 2024-08-01 | Jvckenwood Corporation | 3MP Color LCD Monitor (CL-S301) 摘要 |
| K241441 | 2024-07-16 | Eizo Corporation | RadiForce RX670; RadiForce RX670-AR 摘要 |
| K241499 | 2024-06-13 | Acula Technology Corp. | 21.3 5MP Color LCD Display UMD5-21B01 摘要 |
| K233336 | 2024-05-21 | Acula Technology Corp. | 21.3 3MP Color LCD Display UMD3-21B01 (MD3-21B01) 摘要 |
| K240310 | 2024-03-29 | Shenzhen Beacon Display Technology Co. | LCD Monitors C310S, G310S, C316S, G316S, C616W 摘要 |
| K240130 | 2024-02-15 | Lg Electronics.Inc | Medical Monitor (21HQ613D) 摘要 |
| K233897 | 2024-02-06 | Shenzhen Beacon Display Technology Co. | 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors 摘要 |
| K233465 | 2023-12-21 | Eizo Corporation | RadiForce MX317W 摘要 |
| K233693 | 2023-12-11 | Barco N.V. | Nio Color 8MP (MDNC-8132) 摘要 |
| K232985 | 2023-12-11 | Lg Electronics.Inc | 24HR513C 摘要 |
FDA 官方分类页： PGY
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。