Display, Diagnostic Radiology
FDA product code PGY · Class II (moderate risk) · 21 CFR 892.2050 · Radiology
The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.
136510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Eizo Corporation 26
- Nanjing Jusha Display Technology Co., Ltd. 22
- Jvckenwood Corporation 16
- Wide Corporation 14
- Shenzhen Beacon Display Technology Co., Ltd. 13
- Barco N.V. 12
- Lg Electronics.Inc 12
- Qingdao Hisense Medical Equipment Co., Ltd. 5
- Nec Display Solutions , Ltd. 3
- The Linden Group Corp 2
- Qubyx Software Technologies, Inc. 2
- Qubyx Limited 2
- Acula Technology Corp. 2
- Barco 1
- Canon, Inc. 1
- Kostec Co., Ltd. 1
- Benq Corporation 1
- Quantum-Spectra, LLC 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262783 | RadiForce MX247WPGY · Abbreviated | Eizo Corporation | 09/01/2026SE |
| K261213 | Medical Monitor (40HT513D)PGY · Traditional | Lg Electronics.Inc | 06/12/2026SE |
| K252780 | LCD Monitor (CL1902A, CL2103F)PGY · Traditional | Shenzhen Beacon Display Technology Co., Ltd. | 12/19/2025SE |
| K253242 | LCD Monitor (C1216W, C822W, C821W)PGY · Special | Shenzhen Beacon Display Technology Co., Ltd. | 10/29/2025SE |
| K252030 | RadiForce GX570; RadiForce GX570-ARPGY · Abbreviated | Eizo Corporation | 08/28/2025SE |
| K243221 | RadiForce RX570; RadiForce RX570-ARPGY · Abbreviated | Eizo Corporation | 11/27/2024SE |
| K243031 | LCD Monitors C310S, G310S, C316S, G316S, C616WPGY · Special | Shenzhen Beacon Display Technology Co., Ltd. | 10/25/2024SE |
| K242008 | Coronis OneLookPGY · Special | Barco N.V. | 08/02/2024SE |
| K241105 | 3MP Color LCD Monitor (CL-S301)PGY · Traditional | Jvckenwood Corporation | 08/01/2024SE |
| K241441 | RadiForce RX670; RadiForce RX670-ARPGY · Abbreviated | Eizo Corporation | 07/16/2024SE |
| K241499 | 21.3 5MP Color LCD Display UMD5-21B01PGY · Traditional | Acula Technology Corp. | 06/13/2024SE |
| K233336 | 21.3 3MP Color LCD Display UMD3-21B01 (MD3-21B01)PGY · Traditional | Acula Technology Corp. | 05/21/2024SE |
| K240310 | LCD Monitors C310S, G310S, C316S, G316S, C616WPGY · Traditional | Shenzhen Beacon Display Technology Co., Ltd. | 03/29/2024SE |
| K240130 | Medical Monitor (21HQ613D)PGY · Special | Lg Electronics.Inc | 02/15/2024SE |
| K233897 | 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S…PGY · Traditional | Shenzhen Beacon Display Technology Co., Ltd. | 02/06/2024SE |
| K233465 | RadiForce MX317WPGY · Abbreviated | Eizo Corporation | 12/21/2023SE |
| K233693 | Nio Color 8MP (MDNC-8132)PGY · Special | Barco N.V. | 12/11/2023SE |
| K232985 | 24HR513CPGY · Traditional | Lg Electronics.Inc | 12/11/2023SE |
| K231026 | 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference…PGY · Traditional | Shenzhen Beacon Display Technology Co., Ltd. | 08/18/2023SE |
| K232127 | 21HQ513D, 32HL512D, 31HN713D, 32HQ713DPGY · Special | Lg Electronics.Inc | 08/15/2023SE |
| K230728 | JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD MonitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 06/09/2023SE |
| K231170 | C350/C350G LCD Monitor; M550/M550G LCD MonitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 06/07/2023SE |
| K230723 | C510G/JUSHA-C510G/C510/JUSHA- C510 LCD MonitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 05/18/2023SE |
| K230684 | RadiForce MX217PGY · Abbreviated | Eizo Corporation | 05/12/2023SE |
| K222719 | CX50NPGY · Traditional | Wide Corporation | 05/09/2023SE |
| K222716 | MX50NPGY · Traditional | Wide Corporation | 05/08/2023SE |
| K230643 | CP620G LCD monitor, CP620 LCD monitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 05/01/2023SE |
| K230845 | 32HL512D, 31HN713D, 32HQ713DPGY · Special | Lg Electronics.Inc | 04/27/2023SE |
| K223768 | RadiForce RX270PGY · Abbreviated | Eizo Corporation | 04/20/2023SE |
| K230520 | Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)PGY · Special | Barco N.V. | 03/21/2023SE |
| K223423 | 32HQ713DPGY · Traditional | Lg Electronics.Inc | 03/01/2023SE |
| K223789 | 21HQ513DPGY · Special | Lg Electronics.Inc | 01/09/2023SE |
| K222864 | 8MP Color LCD Monitor CL-R813PGY · Traditional | Jvckenwood Corporation | 12/21/2022SE |
| K222208 | Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30DPGY · Traditional | Qingdao Hisense Medical Equipment Co., Ltd. | 11/17/2022SE |
| K222132 | Hisense LCD monitor HMD2G21S, HMD3G21SPGY · Traditional | Qingdao Hisense Medical Equipment Co., Ltd. | 11/08/2022SE |
| K222722 | CW60NPGY · Traditional | Wide Corporation | 10/31/2022SE |
| K222717 | CL24NPGY · Traditional | Wide Corporation | 10/31/2022SE |
| K222121 | C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 09/19/2022SE |
| K221567 | LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)PGY · Traditional | Qingdao Hisense Medical Equipment Co., Ltd. | 07/26/2022SE |
| K221061 | 21HQ613DPGY · Traditional | Lg Electronics.Inc | 06/03/2022SE |
| K221136 | RadiForce MX243WPGY · Abbreviated | Eizo Corporation | 05/10/2022SE |
| K212231 | C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD MonitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 03/25/2022SE |
| K212985 | 6MP Color LCD Monitor CL-S600PGY · Traditional | Jvckenwood Corporation | 12/16/2021SE |
| K212295 | 21HQ513DPGY · Traditional | Lg Electronics.Inc | 12/03/2021SE |
| K211491 | RadiForce RX370PGY · Abbreviated | Eizo Corporation | 07/12/2021SE |
| K203733 | 12MP Color Digital Mammography LCD Monitor CL-S1200PGY · Traditional | Jvckenwood Corporation | 06/29/2021SE |
| K210345 | 2MP Monochrome LCD Monitor MS-S200PGY · Traditional | Jvckenwood Corporation | 04/23/2021SE |
| K210493 | CX30N (CX30PQX)PGY · Traditional | Wide Corporation | 04/14/2021SE |
| K210491 | CW120NPGY · Traditional | Wide Corporation | 04/08/2021SE |
| K203106 | Nio Fusion 12MP (MDNC-12130)PGY · Special | Barco N.V. | 11/10/2020SE |
| K202374 | 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+PGY · Traditional | Shenzhen Beacon Display Technology Co., Ltd. | 10/19/2020SE |
| K201777 | 31HN713DPGY · Traditional | Lg Electronics.Inc | 10/08/2020SE |
| K201211 | 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+PGY · Traditional | Shenzhen Beacon Display Technology Co., Ltd. | 09/03/2020SE |
| K200742 | JUSHA-CP610 LCD MonitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 07/24/2020SE |
| K201599 | 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+PGY · Traditional | Shenzhen Beacon Display Technology Co., Ltd. | 07/02/2020SE |
| K200889 | iMac 27 & PL 4.0PGY · Traditional | Quantum-Spectra, LLC | 06/02/2020SE |
| K200864 | 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+PGY · Traditional | Shenzhen Beacon Display Technology Co., Ltd. | 05/19/2020SE |
| K200485 | RadiForce RX1270, RadiForce RX1270-ARPGY · Abbreviated | Eizo Corporation | 03/23/2020SE |
| K191705 | OptikView GUP2103CMIPGY · Traditional | The Linden Group Corp | 03/16/2020SE |
| K192925 | 32HL512DPGY · Traditional | Lg Electronics.Inc | 03/13/2020SE |
| K200161 | 3MP Monochrome Digital Mammography LCD Monitor MS-S300PGY · Traditional | Jvckenwood Corporation | 02/21/2020SE |
| K191864 | 21HK512DPGY · Traditional | Lg Electronics.Inc | 12/05/2019SE |
| K191845 | Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools…PGY · Traditional | Barco N.V. | 09/06/2019SE |
| K191137 | 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500PGY · Traditional | Jvckenwood Corporation | 07/02/2019SE |
| K190848 | JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD MonitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 05/14/2019SE |
| K183496 | JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD MonitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 04/08/2019SE |
| K183494 | R190/R191 LCD MonitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 04/05/2019SE |
| K183492 | JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD MonitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 03/13/2019SE |
| K190153 | RadiForce MX216PGY · Abbreviated | Eizo Corporation | 03/08/2019SE |
| K183498 | JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD MonitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 02/05/2019SE |
| K183499 | JUSHA-M350G/JUSHA-M350/M350G/M350 LCD MonitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 02/04/2019SE |
| K183497 | JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD MonitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 01/15/2019SE |
| K182291 | 6MP Color LCD Monitor (C61W+)PGY · Traditional | Shenzhen Beacon Display Technology Co., Ltd. | 11/20/2018SE |
| K182591 | RadiForce RX360, RX360-ARPGY · Abbreviated | Eizo Corporation | 10/18/2018SE |
| K182539 | 2MP Color LCD Monitor CL-R211PGY · Traditional | Jvckenwood Corporation | 10/03/2018SE |
| K181609 | RadiForce GX560, GX560-ARPGY · Abbreviated | Eizo Corporation | 08/24/2018SE |
| K180961 | RadiForce MX194PGY · Abbreviated | Eizo Corporation | 05/10/2018SE |
| K173434 | 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300PGY · Traditional | Jvckenwood Corporation | 12/14/2017SE |
| K172738 | RadiForce RX560, RX560-ARPGY · Traditional | Eizo Corporation | 11/08/2017SE |
| K172815 | 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)PGY · Traditional | Shenzhen Beacon Display Technology Co., Ltd. | 10/27/2017SE |
| K171812 | Nio Color 2MP (MDNC-2123)PGY · Special | Barco N.V. | 07/19/2017SE |
| K171229 | DELL UP3017 with QUBYX PerfectLum bundlePGY · Traditional | Qubyx Software Technologies, Inc. | 05/26/2017SE |
| K170944 | LCD Monitor (MD310C, MD310G, MD210G)PGY · Traditional | Benq Corporation | 05/25/2017SE |
| K170949 | RadiForce MX315WPGY · Traditional | Eizo Corporation | 04/27/2017SE |
| K170837 | Nio Color 3MP (MDNC-3421)PGY · Special | Barco N.V. | 04/05/2017SE |
| K170781 | MX50N(MX50YQS)PGY · Traditional | Wide Corporation | 04/04/2017SE |
| K170783 | CX50N(CX50YQS)PGY · Traditional | Wide Corporation | 03/31/2017SE |
| K170476 | Nio Color 5.8MP (MDNC-6121)PGY · Special | Barco N.V. | 03/28/2017SE |
| K163335 | 6MP Color LCD Monitor, RadiForce RX660, RX660-ARPGY · Traditional | Eizo Corporation | 12/15/2016SE |
| K162527 | 8MP Color LCD Monitor (C81W+)PGY · Traditional | Shenzhen Beacon Display Technology Co., Ltd. | 09/30/2016SE |
| K162497 | 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-ARPGY · Traditional | Eizo Corporation | 09/19/2016SE |
| K161895 | 2MP Color LCD Monitor CCL214 (CL21214)PGY · Traditional | Jvckenwood Corporation | 09/08/2016SE |
| K162196 | Dell UP3216Q with QUBYX PerfectLum bundlePGY · Traditional | Qubyx Software Technologies, Inc. | 08/15/2016SE |
| K161229 | Mammo Tomosynthesis (MDMG-5221)PGY · Special | Barco N.V. | 05/18/2016SE |
| K161057 | Diagnostic Imaging Color LCD MonitorPGY · Traditional | Nec Display Solutions , Ltd. | 05/13/2016SE |
| K160354 | MX50T(MX50TQS)PGY · Traditional | Wide Corporation | 05/02/2016SE |
| K160353 | MX50N(MX50YQS)PGY · Traditional | Wide Corporation | 04/22/2016SE |
| K160348 | CX30N (CX30PQX)PGY · Traditional | Wide Corporation | 04/14/2016SE |
| K160346 | MX30N(MX30TQS)PGY · Traditional | Wide Corporation | 04/14/2016SE |
| K160355 | CX20N(CX20PUX)PGY · Traditional | Wide Corporation | 04/07/2016SE |
| K160351 | CX50N, CX50YQSPGY · Traditional | Wide Corporation | 04/07/2016SE |
| K160347 | Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21PGY · Traditional | Qingdao Hisense Medical Equipment Co., Ltd. | 03/03/2016SE |
| K160328 | DIVA ZSP2105CMI with QUBYX PerfectLum bundlePGY · Traditional | The Linden Group Corp | 02/25/2016SE |
| K160326 | 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)PGY · Traditional | Jvckenwood Corporation | 02/23/2016SE |
| K160247 | 2MP Color LCD Monitor, RadiForce RX250 and RX250-ARPGY · Traditional | Eizo Corporation | 02/23/2016SE |
| K153354 | 3MP Color LCD Monitor, RadiForce RX350PGY · Traditional | Eizo Corporation | 01/12/2016SE |
| K152713 | 8MP Color LCD Monitor, RadiForce RX850, RX850-ARPGY · Traditional | Eizo Corporation | 11/20/2015SE |
| K152847 | DIVA ZSP5812CMI with QUBYX PerfectLum bundlePGY · Traditional | Qubyx , Ltd. | 11/17/2015SE |
| K152030 | Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)PGY · Traditional | Qingdao Hisense Medical Equipment Co., Ltd. | 09/16/2015SE |
| K151972 | JUSHA-C43 LCD MonitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 09/10/2015SE |
| K151861 | JUSHA-C23C LCD MonitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 09/10/2015SE |
| K151883 | 5MP Monochrome LCD Monitor, RadiForce GX540PGY · Traditional | Eizo Corporation | 07/30/2015SE |
| K151505 | Coronis UnitiPGY · Traditional | Barco N.V. | 07/17/2015SE |
| K151238 | JUSHA-M23C LCD MonitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 06/12/2015SE |
| K151134 | 21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)PGY · Traditional | Jvckenwood Corporation | 05/27/2015SE |
| K151007 | 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)PGY · Traditional | Jvckenwood Corporation | 05/08/2015SE |
| K150842 | JUSHA-M53 Medical DisplayPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 04/28/2015SE |
| K150746 | JUSHA-M52C Medical DisplayPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 04/14/2015SE |
| K150821 | MDNG-3220 (Nio 3MP LED)PGY · Special | Barco | 04/10/2015SE |
| K150106 | 2MP Color LCD Monitor, RadiForce RS240PGY · Traditional | Eizo Corporation | 04/03/2015SE |
| K150145 | MD322C8 31.5 Diagnostic Imaging LCD MonitorPGY · Traditional | Nec Display Solutions , Ltd. | 02/06/2015SE |
| K143718 | Mammography Color Display DP-M3010PGY · Traditional | Canon, Inc. | 01/22/2015SE |
| K142951 | MD210C3 21.3 Diagnostic Imaging LCD MonitorPGY · Traditional | Nec Display Solutions , Ltd. | 12/10/2014SE |
| K143261 | 2.3MP Color LCD Monitor, RadiForce MX242WPGY · Traditional | Eizo Corporation | 11/21/2014SE |
| K143098 | 3MP Color LCD monitor, RadiForce RS340PGY · Traditional | Eizo Corporation | 11/18/2014SE |
| K143157 | Coronis Fusion 4MP LEDPGY · Special | Barco N.V. | 11/12/2014SE |
| K143076 | 20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205)PGY · Traditional | Jvckenwood Corporation | 11/12/2014SE |
| K142540 | 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)PGY · Traditional | Jvckenwood Corporation | 10/03/2014SE |
| K142536 | 21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)PGY · Traditional | Jvckenwood Corporation | 10/03/2014SE |
| K141891 | Medical LCD MonitorPGY · Traditional | Kostec Co., Ltd. | 08/04/2014SE |
| K141690 | JUSHA-M33C LCD MonitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 08/01/2014SE |
| K141684 | JUSHA-C33C LCD MonitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 08/01/2014SE |
| K141679 | JUSHA-C61 LCD MonitorPGY · Traditional | Nanjing Jusha Display Technology Co., Ltd. | 08/01/2014SE |
| K131601 | Dell U3014 with Qubyx Perfectlum BundlePGY · Traditional | Qubyx Limited | 07/07/2014SE |
| K141428 | MDMC-12133PGY · Traditional | Barco N.V. | 06/27/2014SE |
| K140702 | 8MP Color LCD Monitor, Radiforce RX850PGY · Traditional | Eizo Corporation | 04/04/2014SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1172-2021 Class II | Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGYA number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass… | Barco N.V. | 01/22/2021Terminated |
| Z-2294-2020 Class II | RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for…Under certain conditions, a marble pattern infrequently appears on the monitor. | Eizo Corporation | 07/30/2019Open, Classified |
| Z-2293-2020 Class II | RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is…Under certain conditions, a marble pattern infrequently appears on the monitor. | Eizo Corporation | 07/30/2019Open, Classified |
| Z-2089-2015 Class II | RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This…EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular… | Eizo Corporation | 07/07/2015Terminated |
| Z-2088-2015 Class II | RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC…EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular… | Eizo Corporation | 07/07/2015Terminated |
| Z-2087-2015 Class II | RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5…EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular… | Eizo Corporation | 07/07/2015Terminated |