RadiForce®
The filing identifies the RadiForce GX570 as a monochrome LCD monitor for viewing medical images, including mammography images. Its stated use is review, analysis and diagnosis of clinical…
The filing identifies the RadiForce GX570 as a monochrome LCD monitor for viewing medical images, including mammography images.
Its stated use is review, analysis and diagnosis of clinical radiological images by trained medical practitioners.
Listed Item
5MP Monochrome LCD Monitor
Model Variations and Screen Finish
The filing describes two variations: GX570 and GX570-AR. It distinguishes their screen surface treatments as anti-glare and anti-reflection, respectively. The panel uses in-plane switching and has a 2,048 by 2,560 pixel matrix.
5manufacturers in China registered for this device type
108catalogue numbers in this listing
26510(k) clearances naming this product code
5recalls on this code
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 | Eizo Corporation, Japan |
|---|---|
| FDA product code | PGY |
| Device type | Display, Diagnostic Radiology |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K252030 |
| Record published | 2025-09-08 |
| Record revised | 2024-05-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Packaging | Box of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GX570 | In distribution | |
| MX243W | In distribution | |
| RX560 | In distribution | |
| MX243W | In distribution | |
| RX570A | In distribution | |
| MX315W | In distribution | |
| MX216 | In distribution | |
| RX670A | In distribution | |
| RX560 | In distribution | |
| RX370A | In distribution | |
| RX660 | In distribution | |
| GX560 | In distribution | |
| RX270A | In distribution | |
| RX560 | In distribution | |
| GX550 | In distribution | |
| MX217 | In distribution | |
| RX370A | In distribution | |
| RX350 | In distribution | |
| MX217A | In distribution | |
| RX660 | In distribution | |
| GX570A | In distribution | |
| MX315W | In distribution | |
| RX370 | In distribution | |
| GX560 | In distribution | |
| RX350 | In distribution | |
| RX570 | In distribution | |
| GX540 | In distribution | |
| GX560 | In distribution | |
| MX243WA | In distribution | |
| RX670 | In distribution | |
| GX570 | In distribution | |
| RX270 | In distribution | |
| GX560 | In distribution | |
| RX570 | In distribution | |
| MX243W | In distribution | |
| RX570A | In distribution | |
| RX270A | In distribution | |
| MX194 | In distribution | |
| GX550 | In distribution | |
| RX360 | In distribution | |
| RX570A | In distribution | |
| RX660 | In distribution | |
| RX850 | In distribution | |
| RX250 | In distribution | |
| RX570A | In distribution | |
| RX1270 | In distribution | |
| GX570 | In distribution | |
| RX560 | In distribution | |
| GX570 | In distribution | |
| RX560 | In distribution | |
| MX317W | In distribution | |
| MX243WA | In distribution | |
| GX560 | In distribution | |
| MX242W | In distribution | |
| RX360 | In distribution | |
| RX850 | In distribution | |
| MX194A | In distribution | |
| RX570A | In distribution | |
| GX570A | In distribution | |
| RX1270 | In distribution | |
| MX317WA | In distribution | |
| RX560 | In distribution | |
| RX1270A | In distribution | |
| MX216 | In distribution | |
| GX550 | In distribution | |
| RX360 | In distribution | |
| GX550 | In distribution | |
| RX250 | In distribution | |
| RX1270A | In distribution | |
| RX560 | In distribution | |
| GX560 | In distribution | |
| RX370 | In distribution | |
| RX570 | In distribution | |
| RX570 | In distribution | |
| RX850 | In distribution | |
| GX570 | In distribution | |
| RX1270 | In distribution | |
| MX243WA | In distribution | |
| RX360 | In distribution | |
| RX570 | In distribution | |
| RX850 | In distribution | |
| RX670A | In distribution | |
| MX242W | In distribution | |
| MX194 | In distribution | |
| MX217A | In distribution | |
| RX250 | In distribution | |
| GX570A | In distribution | |
| GX540 | In distribution | |
| RX370 | In distribution | |
| RX660 | In distribution | |
| GX560 | In distribution | |
| MX217 | In distribution | |
| MX194A | In distribution | |
| RX250 | In distribution | |
| RX660 | In distribution | |
| GX560 | In distribution | |
| GX560 | In distribution | |
| RX370A | In distribution | |
| RX1270 | In distribution | |
| RX560 | In distribution | |
| GX560 | In distribution | |
| RX670 | In distribution | |
| MX194 | In distribution | |
| GX570A | In distribution | |
| RX660 | In distribution | |
| GX570A | In distribution | |
| RX1270A | In distribution | |
| RX270 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Coronis 5MP | Barco, Inc | 6 |
Showing 12 of 40. All products under Display, Diagnostic Radiology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262783 | 2026-09-01 |
| K252030 | 2025-08-28 |
| K243221 | 2024-11-27 |
| K241441 | 2024-07-16 |
| K233465 | 2023-12-21 |
| K230684 | 2023-05-12 |
| K223768 | 2023-04-20 |
| K221136 | 2022-05-10 |
| K211491 | 2021-07-12 |
| K200485 | 2020-03-23 |
| K190153 | 2019-03-08 |
| K182591 | 2018-10-18 |
| K181609 | 2018-08-24 |
| K180961 | 2018-05-10 |
| K172738 | 2017-11-08 |
| K170949 | 2017-04-27 |
| K163335 | 2016-12-15 |
| K162497 | 2016-09-19 |
| K160247 | 2016-02-23 |
| K153354 | 2016-01-12 |
| K152713 | 2015-11-20 |
| K151883 | 2015-07-30 |
| K150106 | 2015-04-03 |
| K143261 | 2014-11-21 |
| K143098 | 2014-11-18 |
| K140702 | 2014-04-04 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Eizo Corporation | 510(k) number | 2019-07-30 | Class II | Device Design | Under certain conditions, a marble pattern infrequently appears on the monitor. | 96 monitors dist. to the U.S. |
| Eizo Corporation | 510(k) number | 2019-07-30 | Class II | Device Design | Under certain conditions, a marble pattern infrequently appears on the monitor. | 1,466 monitors dist. to the U.S. |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-07-07 | Class II | Device Design | EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort. | 2 units | 2016-11-30 |
| 2015-07-07 | Class II | Device Design | EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort. | 19 units | 2016-11-30 |
| 2015-07-07 | Class II | Device Design | EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort. | 3 units | 2016-11-30 |
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.