FDA 510(k) Applications for Medical Device Product Code "PGY"

FDA 510(k) Number Applicant Device Name Decision Date
K150821 Barco MDNG-3220 (Nio 3MP LED) 04/10/2015
K151505 Barco N.V. Coronis Uniti 07/17/2015
K161229 BARCO N.V. Mammo Tomosynthesis (MDMG-5221) 05/18/2016
K141428 BARCO N.V. MDMC-12133 06/27/2014
K143157 BARCO NV Coronis Fusion 4MP LED 11/12/2014
K191845 Barco NV Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) 09/06/2019
K171812 Barco NV Nio Color 2MP (MDNC-2123) 07/19/2017
K230520 Barco NV Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) 03/21/2023
K170837 Barco NV Nio Color 3MP (MDNC-3421) 04/05/2017
K170476 Barco NV Nio Color 5.8MP (MDNC-6121) 03/28/2017
K203106 Barco NV Nio Fusion 12MP (MDNC-12130) 11/10/2020
K170944 BenQ Corporation LCD Monitor (MD310C, MD310G, MD210G) 05/25/2017
K143718 CANON INC. Mammography Color Display DP-M3010 01/22/2015
K143261 EIZO CORPORATION 2.3MP Color LCD Monitor, RadiForce MX242W 11/21/2014
K150106 EIZO CORPORATION 2MP Color LCD Monitor, RadiForce RS240 04/03/2015
K160247 EIZO Corporation 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR 02/23/2016
K143098 EIZO CORPORATION 3MP Color LCD monitor, RadiForce RS340 11/18/2014
K153354 EIZO CORPORATION 3MP Color LCD Monitor, RadiForce RX350 01/12/2016
K151883 EIZO CORPORATION 5MP Monochrome LCD Monitor, RadiForce GX540 07/30/2015
K162497 EIZO CORPORATION 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR 09/19/2016
K163335 EIZO CORPORATION 6MP Color LCD Monitor, RadiForce RX660, RX660-AR 12/15/2016
K140702 EIZO CORPORATION 8MP COLOR LCD MONITOR, RADIFORCE RX850 04/04/2014
K152713 EIZO CORPORATION 8MP Color LCD Monitor, RadiForce RX850, RX850-AR 11/20/2015
K181609 EIZO Corporation RadiForce GX560, GX560-AR 08/24/2018
K180961 EIZO Corporation RadiForce MX194 05/10/2018
K190153 EIZO Corporation RadiForce MX216 03/08/2019
K230684 EIZO Corporation RadiForce MX217 05/12/2023
K221136 EIZO Corporation RadiForce MX243W 05/10/2022
K170949 EIZO Corporation RadiForce MX315W 04/27/2017
K200485 EIZO Corporation RadiForce RX1270, RadiForce RX1270-AR 03/23/2020
K223768 EIZO Corporation RadiForce RX270 04/20/2023
K182591 EIZO Corporation RadiForce RX360, RX360-AR 10/18/2018
K211491 EIZO Corporation RadiForce RX370 07/12/2021
K172738 EIZO Corporation RadiForce RX560, RX560-AR 11/08/2017
K143076 JVC KENWOOD CORPORATION 20.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205) 11/12/2014
K151007 JVC KENWOOD CORPORATION 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550) 05/08/2015
K151134 JVC KENWOOD CORPORATION 21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210) 05/27/2015
K142536 JVC KENWOOD CORPORATION 21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220) 10/03/2014
K142540 JVC KENWOOD CORPORATION 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244) 10/03/2014
K161895 JVC KENWOOD Corporation 2MP Color LCD Monitor CCL214 (CL21214) 09/08/2016
K182539 JVC Kenwood Corporation 2MP Color LCD Monitor CL-R211 10/03/2018
K173434 JVC KENWOOD Corporation 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300 12/14/2017
K191137 JVC Kenwood Corporation 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 07/02/2019
K160326 JVC KENWOOD Corporation 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) 02/23/2016
K203733 JVCKENWOOD Corporation 12MP Color Digital Mammography LCD Monitor CL-S1200 06/29/2021
K210345 Jvckenwood Corporation 2MP Monochrome LCD Monitor MS-S200 04/23/2021
K200161 Jvckenwood Corporation 3MP Monochrome Digital Mammography LCD Monitor MS-S300 02/21/2020
K212985 JVCKENWOOD Corporation 6MP Color LCD Monitor CL-S600 12/16/2021
K222864 JVCKENWOOD Corporation 8MP Color LCD Monitor CL-R813 12/21/2022
K141891 KOSTEC CO., LTD MEDICAL LCD MONITOR 08/04/2014
K191864 LG Electronics Inc. 21HK512D 12/05/2019
K223789 LG Electronics Inc. 21HQ513D 01/09/2023
K212295 LG Electronics Inc. 21HQ513D 12/03/2021
K232127 LG Electronics Inc. 21HQ513D, 32HL512D, 31HN713D, 32HQ713D 08/15/2023
K221061 LG Electronics Inc. 21HQ613D 06/03/2022
K201777 LG Electronics Inc. 31HN713D 10/08/2020
K192925 LG Electronics Inc. 32HL512D 03/13/2020
K230845 LG Electronics Inc. 32HL512D, 31HN713D, 32HQ713D 04/27/2023
K223423 LG Electronics Inc. 32HQ713D 03/01/2023
K230723 Nanjing Jusha Display Technology Co., Ltd C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor 05/18/2023
K230643 Nanjing Jusha Display Technology Co., Ltd CP620G LCD monitor, CP620 LCD monitor 05/01/2023
K151861 NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD JUSHA-C23C LCD Monitor 09/10/2015
K141684 NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD JUSHA-C33C LCD MONITOR 08/01/2014
K183496 Nanjing Jusha Display Technology Co., Ltd JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor 04/08/2019
K151972 Nanjing Jusha Display Technology Co., Ltd JUSHA-C43 LCD Monitor 09/10/2015
K141679 NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD JUSHA-C61 LCD MONITOR 08/01/2014
K230728 Nanjing Jusha Display Technology Co., Ltd JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor 06/09/2023
K151238 NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD JUSHA-M23C LCD Monitor 06/12/2015
K141690 NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD JUSHA-M33C LCD MONITOR 08/01/2014
K183499 Nanjing Jusha Display Technology Co., Ltd JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor 02/04/2019
K150746 NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD JUSHA-M52C Medical Display 04/14/2015
K150842 NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD JUSHA-M53 Medical Display 04/28/2015
K190848 Nanjing Jusha Display Technology Co., Ltd JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor 05/14/2019
K212231 Nanjing Jusha Display Technology Co., Ltd. C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor 03/25/2022
K231170 Nanjing Jusha Display Technology Co., Ltd. C350/C350G LCD Monitor; M550/M550G LCD Monitor 06/07/2023
K222121 Nanjing Jusha Display Technology Co., Ltd. C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor 09/19/2022
K183498 Nanjing Jusha Display Technology Co., Ltd. JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor 02/05/2019
K183492 Nanjing Jusha Display Technology Co., Ltd. JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor 03/13/2019
K200742 Nanjing Jusha Display Technology Co., Ltd. JUSHA-CP610 LCD Monitor 07/24/2020
K183497 Nanjing Jusha Display Technology Co., Ltd. JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor 01/15/2019
K183494 Nanjing Jusha Display Technology Co., Ltd. R190/R191 LCD Monitor 04/05/2019
K161057 NEC DISPLAY SOLUTIONS LTD. Diagnostic Imaging Color LCD Monitor 05/13/2016
K142951 NEC DISPLAY SOLUTIONS LTD. MD210C3 21.3 Diagnostic Imaging LCD Monitor 12/10/2014
K150145 NEC DISPLAY SOLUTIONS LTD. MD322C8 31.5 Diagnostic Imaging LCD Monitor 02/06/2015
K222208 Qingdao Hisense Medical Equipment Co., Ltd Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D 11/17/2022
K222132 Qingdao Hisense Medical Equipment Co., Ltd Hisense LCD monitor HMD2G21S, HMD3G21S 11/08/2022
K152030 Qingdao Hisense Medical Equipment Co., Ltd. Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) 09/16/2015
K221567 Qingdao Hisense Medical Equipment Co., Ltd. LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) 07/26/2022
K160347 QINGDAO HISENSE MEDICAL EQUIPMENT CO.,LTD Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 03/03/2016
K200889 Quantum-Spectra LLC iMac 27 & PL 4.0 06/02/2020
K131601 QUBYX LIMITED DELL U3014 WITH QUBYX PERFECTLUM BUNDLE 07/07/2014
K152847 QUBYX LTD. DIVA ZSP5812CMI with QUBYX PerfectLum bundle 11/17/2015
K171229 Qubyx Software Technologies Inc. DELL UP3017 with QUBYX PerfectLum bundle 05/26/2017
K162196 QUBYX SOFTWARE TECHNOLOGIES INC. Dell UP3216Q with QUBYX PerfectLum bundle 08/15/2016
K201599 Shenzhen Beacon Display Technology Co., Ltd. 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ 07/02/2020
K172815 Shenzhen Beacon Display Technology Co., Ltd. 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) 10/27/2017
K201211 Shenzhen Beacon Display Technology Co., Ltd. 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+ 09/03/2020
K202374 Shenzhen Beacon Display Technology Co., Ltd. 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+ 10/19/2020
K200864 Shenzhen Beacon Display Technology Co., Ltd. 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ 05/19/2020
K182291 Shenzhen Beacon Display Technology Co., Ltd. 6MP Color LCD Monitor (C61W+) 11/20/2018
K162527 Shenzhen Beacon Display Technology Co., Ltd. 8MP Color LCD Monitor (C81W+) 09/30/2016
K231026 Shenzhen Beacon Display Technology Co.,Ltd. 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) 08/18/2023
K191705 The Linden Group Corp OptikView GUP2103CMI 03/16/2020
K160328 THE LINDEN GROUP CORP. DIVA ZSP2105CMI with QUBYX PerfectLum bundle 02/25/2016
K222717 WIDE Corporation CL24N 10/31/2022
K210491 Wide Corporation CW120N 04/08/2021
K222722 WIDE Corporation CW60N 10/31/2022
K160355 WIDE Corporation CX20N(CX20PUX) 04/07/2016
K160348 WIDE CORPORATION CX30N (CX30PQX) 04/14/2016
K210493 Wide Corporation CX30N (CX30PQX) 04/14/2021
K222719 WIDE Corporation CX50N 05/09/2023
K160351 WIDE Corporation CX50N, CX50YQS 04/07/2016
K170783 WIDE Corporation CX50N(CX50YQS) 03/31/2017
K160346 WIDE Corporation MX30N(MX30TQS) 04/14/2016
K222716 WIDE Corporation MX50N 05/08/2023
K160353 WIDE Corporation MX50N(MX50YQS) 04/22/2016
K170781 WIDE Corporation MX50N(MX50YQS) 04/04/2017
K160354 WIDE CORPORATION MX50T(MX50TQS) 05/02/2016


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact