CW60N
The FDA filing identifies CW60N as an LCD medical monitor for displaying digital medical images for trained medical practitioners. It is intended for high-resolution color and grayscale…
The FDA filing identifies CW60N as an LCD medical monitor for displaying digital medical images for trained medical practitioners.
It is intended for high-resolution color and grayscale medical imaging in PACS and radiology systems and does not support mammography diagnosis.
Display Profile
The filing identifies a TFT color LCD panel and describes the monitor as a medical image display used by trained practitioners to review images. EzCal version 2 can modify output to meet DICOM Part 14 GSDF and other industry standards.
Who Else Makes It
Concentrated in Jiangsu (3), Shandong (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Barco (Suzhou) Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Nanjing Jusha Display Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 7 |
| Qingdao Hisense Medical Equipment Co., Ltd. | Qingdao | Shandong | Manufacturer | 5 |
| LG Electronics Nanjing New Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 4 |
| Shenzhen Beacon Display Technology Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 2 |
Record
| Listed by | Wide Corporation, United States |
|---|---|
| FDA product code | PGY |
| Device type | Display, Diagnostic Radiology |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| 510(k) | K222722 |
| Record published | 2026-07-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CW60N | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RadiForce® | Eizo Corporation | 108 |
| Beacon | Shenzhen Beacon Display Technology Co., Ltd. | 33 |
| JVC | JVC Kenwood Corporation | 20 |
| Nio Color 3MP | Barco, Inc | 18 |
| Jusha | Nanjing Jusha Display Technology Co., Ltd. | 16 |
| Nio Color 2MP | Barco, Inc | 14 |
| Totoku | JVC Kenwood Corporation | 11 |
| LG | LG Electronics Inc. | 11 |
| Nio 5.8MP Gray | Barco, Inc | 8 |
| Hisense | Qingdao Hisense Medical Equipment Co., Ltd. | 7 |
| Coronis Fusion 4MP | Barco, Inc | 7 |
| Coronis Fusion 6MP | Barco, Inc | 6 |
Showing 12 of 40. All products under Display, Diagnostic Radiology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222719 | 2023-05-09 |
| K222716 | 2023-05-08 |
| K222717 | 2022-10-31 |
| K222722 | 2022-10-31 |
| K210493 | 2021-04-14 |
| K210491 | 2021-04-08 |
| K170781 | 2017-04-04 |
| K170783 | 2017-03-31 |
| K160354 | 2016-05-02 |
| K160353 | 2016-04-22 |
| K160346 | 2016-04-14 |
| K160348 | 2016-04-14 |
| K160351 | 2016-04-07 |
| K160355 | 2016-04-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.