PGY · Display, Diagnostic Radiology
Radiology · 21 CFR 892.2050 · Class 2
Overview
| Product Code | PGY |
|---|---|
| Device Name | Display, Diagnostic Radiology |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Classification Rationale
Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Recent Cleared Devices (20 of 134)
Showing 20 most recent of 134 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252780 | LCD Monitor (CL1902A, CL2103F) | Shenzhen Beacon Display Technology Co., Ltd. | Dec 19, 2025 | SESE |
| K253242 | LCD Monitor (C1216W, C822W, C821W) | Shenzhen Beacon Display Technology Co., Ltd. | Oct 29, 2025 | SESE |
| K252030 | RadiForce GX570; RadiForce GX570-AR | Eizo Corporation | Aug 28, 2025 | SESE |
| K243221 | RadiForce RX570; RadiForce RX570-AR | Eizo Corporation | Nov 27, 2024 | SESE |
| K243031 | LCD Monitors C310S, G310S, C316S, G316S, C616W | Shenzhen Beacon Display Technology Co., Ltd. | Oct 25, 2024 | SESE |
| K242008 | Coronis OneLook | Barco N.V. | Aug 2, 2024 | SESE |
| K241105 | 3MP Color LCD Monitor (CL-S301) | Jvckenwood Corporation | Aug 1, 2024 | SESE |
| K241441 | RadiForce RX670; RadiForce RX670-AR | Eizo Corporation | Jul 16, 2024 | SESE |
| K241499 | 21.3 5MP Color LCD Display UMD5-21B01 | Acula Technology Corp. | Jun 13, 2024 | SESE |
| K233336 | 21.3 3MP Color LCD Display UMD3-21B01 (MD3-21B01) | Acula Technology Corp. | May 21, 2024 | SESE |
| K240310 | LCD Monitors C310S, G310S, C316S, G316S, C616W | Shenzhen Beacon Display Technology Co., Ltd. | Mar 29, 2024 | SESE |
| K240130 | Medical Monitor (21HQ613D) | Lg Electronics.Inc | Feb 15, 2024 | SESE |
| K233897 | 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S) | Shenzhen Beacon Display Technology Co., Ltd. | Feb 6, 2024 | SESE |
| K233465 | RadiForce MX317W | Eizo Corporation | Dec 21, 2023 | SESE |
| K233693 | Nio Color 8MP (MDNC-8132) | Barco N.V. | Dec 11, 2023 | SESE |
| K232985 | 24HR513C | Lg Electronics.Inc | Dec 11, 2023 | SESE |
| 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. | Aug 18, 2023 | SESE |
| K232127 | 21HQ513D, 32HL512D, 31HN713D, 32HQ713D | Lg Electronics.Inc | Aug 15, 2023 | SESE |
| K230728 | JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | Jun 9, 2023 | SESE |
| K231170 | C350/C350G LCD Monitor; M550/M550G LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | Jun 7, 2023 | SESE |
Top Applicants
- Eizo Corporation — 25 clearances
- Nanjing Jusha Display Technology Co., Ltd. — 22 clearances
- Jvckenwood Corporation — 16 clearances
- Wide Corporation — 14 clearances
- Shenzhen Beacon Display Technology Co., Ltd. — 13 clearances
