Nio Color 3MP
MDNC-3421 HLX Mkii
5manufacturers in China registered for this device type
18catalogue numbers in this listing
1510(k) clearance
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) | K170837 |
| Record published | 2017-04-11 |
| Record revised | 2026-07-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-08-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MDNC-3421II | In distribution | |
| MDNC-3521 | In distribution | |
| MDNC-3521 | In distribution | |
| MDNC-3421 | In distribution | |
| MDNC-3521 | In distribution | |
| MDNC-3421 | In distribution | |
| MDNC-3421 | In distribution | |
| MDNC-3521 | In distribution | |
| MDNC-3421 | In distribution | |
| mdnc-3421 | In distribution | |
| MDNC-3521 | In distribution | |
| MDNC-3521 | In distribution | |
| MDNC-3421 | In distribution | |
| MDNC-3521 | In distribution | |
| MDNC-3421 | In distribution | |
| MDNC-3521 | In distribution | |
| MDNC-3421 | Withdrawn | |
| MDNC-3421 | Withdrawn |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 |
| 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 |
| Coronis 5MP | Barco, Inc | 6 |
Showing 12 of 40. All products under Display, Diagnostic Radiology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150821 | 2015-04-10 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Barco N.V. | 510(k) number | 2021-01-22 | Class II | Process change control | A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests. | 1 unit | 2022-11-18 |
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.