CW120N
CW120N is an LCD medical monitor for presenting high-resolution color and grayscale medical images in PACS and radiology systems. The filing identifies trained medical practitioners as…
CW120N is an LCD medical monitor for presenting high-resolution color and grayscale medical images in PACS and radiology systems. The filing identifies trained medical practitioners as users who display, review and analyze the images.
EzCal version 2 is the calibration software associated with CW120N. It lets users modify display output to meet DICOM Part 14 GSDF and other industry standards. The submission says the software is provided with the monitor when requested by the customer.
Listed Item
CW120N LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and digital breast tomosynthesis applications.
Display and Calibration
The submission says EzCal version 2 is provided with the monitor when requested by the customer. Its described role is display calibration for practitioner review and analysis of medical images.
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) | K210491 |
| Record published | 2021-04-20 |
| Record revised | 2026-07-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CW120N | 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.