Product code PGY
- Device name
- Display, Diagnostic Radiology
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.2050
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252780 | LCD Monitor (CL1902A, CL2103F) | Shenzhen Beacon Display Technology Co., Ltd. | 2025-12-19 |
| K253242 | LCD Monitor (C1216W, C822W, C821W) | Shenzhen Beacon Display Technology Co., Ltd. | 2025-10-29 |
| K252030 | RadiForce GX570; RadiForce GX570-AR | Eizo Corporation | 2025-08-28 |
| K243221 | RadiForce RX570; RadiForce RX570-AR | Eizo Corporation | 2024-11-27 |
| K243031 | LCD Monitors C310S, G310S, C316S, G316S, C616W | Shenzhen Beacon Display Technology Co., Ltd. | 2024-10-25 |
| K242008 | Coronis OneLook | Barco N.V. | 2024-08-02 |
| K241105 | 3MP Color LCD Monitor (CL-S301) | Jvckenwood Corporation | 2024-08-01 |
| K241441 | RadiForce RX670; RadiForce RX670-AR | Eizo Corporation | 2024-07-16 |
| K241499 | 21.3” 5MP Color LCD Display UMD5-21B01 | Acula Technology Corp. | 2024-06-13 |
| K233336 | 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) | Acula Technology Corp. | 2024-05-21 |
| K240310 | LCD Monitors C310S, G310S, C316S, G316S, C616W | Shenzhen Beacon Display Technology Co., Ltd. | 2024-03-29 |
| K240130 | Medical Monitor (21HQ613D) | Lg Electronics.Inc | 2024-02-15 |
| K233897 | 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S) | Shenzhen Beacon Display Technology Co., Ltd. | 2024-02-06 |
| K233465 | RadiForce MX317W | Eizo Corporation | 2023-12-21 |
| K232985 | 24HR513C | Lg Electronics.Inc | 2023-12-11 |
| K233693 | Nio Color 8MP (MDNC-8132) | Barco N.V. | 2023-12-11 |
| K231026 | 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) | Shenzhen Beacon Display Technology Co., Ltd. | 2023-08-18 |
| K232127 | 21HQ513D, 32HL512D, 31HN713D, 32HQ713D | Lg Electronics.Inc | 2023-08-15 |
| K230728 | JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2023-06-09 |
| K231170 | C350/C350G LCD Monitor; M550/M550G LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2023-06-07 |
| K230723 | C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2023-05-18 |
| K230684 | RadiForce MX217 | Eizo Corporation | 2023-05-12 |
| K222719 | CX50N | Wide Corporation | 2023-05-09 |
| K222716 | MX50N | Wide Corporation | 2023-05-08 |
| K230643 | CP620G LCD monitor, CP620 LCD monitor | Nanjing Jusha Display Technology Co., Ltd. | 2023-05-01 |
| K230845 | 32HL512D, 31HN713D, 32HQ713D | Lg Electronics.Inc | 2023-04-27 |
| K223768 | RadiForce RX270 | Eizo Corporation | 2023-04-20 |
| K230520 | Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) | Barco N.V. | 2023-03-21 |
| K223423 | 32HQ713D | Lg Electronics.Inc | 2023-03-01 |
| K223789 | 21HQ513D | Lg Electronics.Inc | 2023-01-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05415334061750 | Barco | Barco NV | 2026-06-02 |
| 06970027821411 | Beacon | Shenzhen Beacon Display Technology Co., Ltd. | 2026-05-27 |
| 05415334057265 | Nio Color 8MP | Barco NV | 2026-05-07 |
| 04719875210211 | DIVA | DIVA LABORATORIES, LTD. | 2026-04-21 |
| 04719875210525 | DIVA | DIVA LABORATORIES, LTD. | 2026-04-21 |
| 05415334060159 | Nio 5.8MP Gray | Barco NV | 2025-12-01 |
| 08806096660263 | LG | LG Electronics Inc. | 2025-09-19 |
| 04995047070542 | RadiForce® | EIZO CORPORATION | 2025-09-12 |
| 04995047060611 | RadiForce® | EIZO CORPORATION | 2025-09-08 |
| 04995047060567 | RadiForce® | EIZO CORPORATION | 2025-09-08 |
| 04995047060727 | RadiForce® | EIZO CORPORATION | 2025-09-08 |
| 04995047068259 | RadiForce® | EIZO CORPORATION | 2025-07-11 |
| 04995047068341 | RadiForce® | EIZO CORPORATION | 2024-12-05 |
| 04995047068044 | RadiForce® | EIZO CORPORATION | 2024-12-05 |
| 04719896530060 | LUMIN | ACULA TECHNOLOGY CORPORATION | 2024-10-29 |
| 04995047059295 | RadiForce® | EIZO CORPORATION | 2021-07-30 |
| 04995047059585 | RadiForce® | EIZO CORPORATION | 2021-07-30 |
| 04995047059486 | RadiForce® | EIZO CORPORATION | 2021-07-30 |
| 04995047059264 | RadiForce® | EIZO CORPORATION | 2021-07-30 |
| 05415334028333 | Nio Color 3MP | Barco NV | 2020-11-03 |
| 05415334028357 | Nio Color 3MP | Barco NV | 2020-11-03 |
| 05415334028371 | Nio Color 3MP | Barco NV | 2020-11-03 |
| 05415334028388 | Nio Color 3MP | Barco NV | 2020-11-03 |
| 05415334031326 | Nio Color 3MP | Barco NV | 2020-11-03 |
| 04995047053255 | RadiForce® | EIZO CORPORATION | 2018-09-04 |
| 04995047051442 | RadiForce® | EIZO CORPORATION | 2017-11-16 |
| 04995047051404 | RadiForce® | EIZO CORPORATION | 2017-11-16 |
| 04995047048305 | RadiForce® | EIZO CORPORATION | 2016-09-27 |
| 04995047048268 | RadiForce® | EIZO CORPORATION | 2016-09-27 |
| 04995047041726 | RadiForce® | EIZO CORPORATION | 2016-09-12 |