PGY — Display, Diagnostic Radiology Class II
FDA product code PGY covers "Display, Diagnostic Radiology", a Class II medical device regulated under 21 CFR 892.2050. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PGY
- Device Class
- Class II
- Regulation Number
- 892.2050
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Definition
The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K262783 | eizo corporation | RadiForce MX247W | September 1, 2026 |
| K261213 | lg electronics | Medical Monitor (40HT513D) | June 12, 2026 |
| K252780 | shenzhen beacon display technology co | LCD Monitor (CL1902A, CL2103F) | December 19, 2025 |
| K253242 | shenzhen beacon display technology co | LCD Monitor (C1216W, C822W, C821W) | October 29, 2025 |
| K252030 | eizo corporation | RadiForce GX570; RadiForce GX570-AR | August 28, 2025 |
| K243221 | eizo corporation | RadiForce RX570; RadiForce RX570-AR | November 27, 2024 |
| K243031 | shenzhen beacon display technology co | LCD Monitors C310S, G310S, C316S, G316S, C616W | October 25, 2024 |
| K242008 | barco n.v | Coronis OneLook | August 2, 2024 |
| K241105 | jvckenwood corporation | 3MP Color LCD Monitor (CL-S301) | August 1, 2024 |
| K241441 | eizo corporation | RadiForce RX670; RadiForce RX670-AR | July 16, 2024 |
| K241499 | acula technology | 21.3 5MP Color LCD Display UMD5-21B01 | June 13, 2024 |
| K233336 | acula technology | 21.3 3MP Color LCD Display UMD3-21B01 (MD3-21B01) | May 21, 2024 |
| K240310 | shenzhen beacon display technology co | LCD Monitors C310S, G310S, C316S, G316S, C616W | March 29, 2024 |
| K240130 | lg electronics | Medical Monitor (21HQ613D) | February 15, 2024 |
| K233897 | shenzhen beacon display technology co | 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, | February 6, 2024 |
| K233465 | eizo corporation | RadiForce MX317W | December 21, 2023 |
| K233693 | barco n.v | Nio Color 8MP (MDNC-8132) | December 11, 2023 |
| K232985 | lg electronics | 24HR513C | December 11, 2023 |
| K231026 | shenzhen beacon display technology co | 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the diff | August 18, 2023 |
| K232127 | lg electronics | 21HQ513D, 32HL512D, 31HN713D, 32HQ713D | August 15, 2023 |