Data / Medical devices / Display, Diagnostic Radiology
Display, Diagnostic Radiology (PGY): 16 FDA-registered makers in 7 countries
16 establishments in 7 countries are registered with the FDA to make Display, Diagnostic Radiology (product code PGY, Class 2, 21 CFR 892.2050). 13 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 138 510(k) clearances under this code, the latest on October 2, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PGY
- Device class
- 2
- Regulation
- 892.2050
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| China | 5 |
| South Korea | 3 |
| Japan | 2 |
| United States | 2 |
| Taiwan | 2 |
| Belgium | 1 |
| Italy | 1 |
Makers of Display, Diagnostic Radiology
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Eizo Corporation | HAKUSAN Ishikawa, Japan | Manufacturer | 22 | September 1, 2026 | 0 | 2 | 0 | api.fda.gov |
| Nanjing Jusha Display Technology Co., Ltd | Nanjing Jiangsu, China | Manufacturer | 15 | June 9, 2023 | 0 | 0 | 0 | api.fda.gov |
| LG Electronics Inc. | Gumi-si Gyeongbuk, South Korea | Exporter to the US, Manufacturer | 11 | June 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| LG Electronics Nanjing New Technology Co., Ltd. | Nanjing Jiangsu, China | Exporter to the US, Manufacturer | 11 | June 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Barco N.V. | KORTRIJK West-Vlaanderen, Belgium | Manufacturer | 10 | August 2, 2024 | 0 | 1 | 0 | api.fda.gov |
| JVCKENWOOD Corporation | Yokohama-shi Kanagawa, Japan | Complaint file establishment, Manufacturer, Specification developer | 9 | August 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Foreseeson Custom Displays, Inc. | Anaheim, CA, United States | Complaint file establishment, Remanufacturer | 8 | October 31, 2022 | 0 | 0 | 0 | api.fda.gov |
| Qingdao Hisense Medical Equipment Co.,Ltd. | Qingdao Shandong, China | Manufacturer | 3 | November 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Beacon Display Technology Co., Ltd. | Shenzhen Guangdong, China | Complaint file establishment, Manufacturer | 3 | October 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Acula Technology Corp | Luchu Taoyuan, Taiwan | Manufacturer | 2 | June 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Diva Laboratories, Ltd. | New Taipei City, Taipei-District, 235, Taiwan | Manufacturer | 2 | March 16, 2020 | 0 | 0 | 0 | api.fda.gov |
| Beacon Korea Inc. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | October 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| Barco Inc Portland | Portland, OR, United States | Manufacturer | 1 | September 6, 2019 | 0 | 0 | 0 | api.fda.gov |
| Barco S.R.L. | Saronno Varese, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Barco (Suzhou) Healthcare Technology Co., Ltd. | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| D&T Inc. | Yuseong-gu Daejeon, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.