Nio 3MP LED
The Barco Nio 3MP LED MDNG-3220 is a grayscale flat panel display for reviewing and analyzing medical images. It is intended for trained medical practitioners and excludes digital…
The Barco Nio 3MP LED MDNG-3220 is a grayscale flat panel display for reviewing and analyzing medical images. It is intended for trained medical practitioners and excludes digital mammography from its viewing applications.
The LED backlit LCD has a three megapixel resolution of 2048 by 1536 pixels and a four to three aspect ratio. It connects to a PACS workstation, with an optional display controller board and quality assurance software supporting the display system.
Listed Item
MDNG-3220 W/O FF CN
Display Consistency
Quality assurance software helps establish and maintain DICOM compliant display behavior. The monitor also provides uniform luminance technology and backlight output stabilization. Digital video inputs include dual link DVI-D and DisplayPort.
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 | Barco, Inc, United States |
|---|---|
| FDA product code | PGY |
| Device type | Display, Diagnostic Radiology |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K150821 |
| Record published | 2016-06-30 |
| Record revised | 2023-10-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-05-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MDNG-3220 | Withdrawn | |
| MDNG-3220 | Withdrawn | |
| MDNG-3220 | Withdrawn | |
| MDNG-3220 | Withdrawn |
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 |
|---|---|
| K150821 | 2015-04-10 |
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.