MX30N
The FDA filing identifies MX30TQS within the MX30N LCD Monitor System, a display for digital medical images. It is intended for review and analysis by trained medical practitioners. The…
The FDA filing identifies MX30TQS within the MX30N LCD Monitor System, a display for digital medical images. It is intended for review and analysis by trained medical practitioners.
The display is not intended for mammography. The summary describes an LCD monitor and graphics control board connected to a PACS workstation for grayscale image display.
Display Setup
The WIDE controller board is installed in the PACS workstation or another computer system to display PACS medical images. The summary lists a 21.3-inch LCD panel.
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) | K160346 |
| Record published | 2016-09-21 |
| Record revised | 2026-07-16 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MX30TQS | 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.