510(k) K242019

Device: GXR-Series Diagnostic X-Ray System
Applicant: DRGEM Corporation
510(k) number: K242019
Product code: KPR
Decision: Substantially Equivalent (SESE)
Decision date: 2025-01-07
Date received: 2024-07-10
Regulation: 892.1680
Classification name: System, X-Ray, Stationary
Medical specialty: Radiology
Review panel: Radiology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Jongseon Park
Address: 7f, E-B/D Gwangmyeong Techno-Park 60, Haan-Ro Gwangmyeong-Si KR 14322 14322

FDA Registration Numbers

3021059265
3035950510
3014209556
3016674851
2433615
1054713
3001722928
3009077524
3013714596
3009001657
3032116890
3004606964
3011015597
3033525986
3006551157
3027339477
3006165260
3009134655
3024891354
3005778458
3011416394
3010300212
3008364043
9617251
2243057
3005810333
3011950073
1450503
3016250464
3013679558
8030233
3003202425
3003768277
2126677
3006051164
3025442726
3015276088
8030112
3012569470
1418964
3006115340
9616014
9616047
3005172103
3000126629
3014293172
3023190435
3009963139
1064396
3023003446
3029916061
3004198450
3005406110
3012624817
3031503890
3004977335
3004756607
1317307
8022065
3004989804
3004077520
3008284470
3007305589
9614430
3001556265
3011825597
3030089787
3009608361
9613445
3009529630
3003769120
3008496839
3033527770
3014403439
1418484
3042864600
3003775006
3009715136
3003768251
3004485675

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code KPR

510(k)	Device	Applicant	Decision date
K253446	AeroDR TX c02	Dk Medical Systems Co., Ltd.	2026-04-10
K250954	DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector	Carestream Health	2026-01-20
K252000	uDR Arria & uDR Aris	Shanghai United Imaging Healthcare Co., Ltd.	2025-11-26
K251167	uDR Aurora CX	Shanghai United Imaging Healthcare Co., Ltd.	2025-09-19
K250788	Definium Tempo Select	Ge Hualun Medical Systems Co. , Ltd.	2025-08-28
K250790	INNOVISION-DXII	Dk Medical Systems Co., Ltd.	2025-08-01
K250738	YSIO X.pree	Siemens Medical Solutions	2025-07-31
K242499	Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))	Shenzhen Sontu Medical Imaging Equipment Co., Ltd.	2025-01-06
K242119	INNOVISION-EXII	Dk Medical System	2025-01-03
K241068	uDR 780i	Shanghai United Imaging Healthcare Co., Ltd.	2024-11-01
K242847	EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);	DRTECH Corporation	2024-10-23
K242678	Definium Pace Select ET	Ge Hualun Medical Systems Co. , Ltd.	2024-10-01
K242478	GF85 (models GF85-3P, GF85-SP)	Samsung Electronics Co., Ltd.	2024-09-19
K233920	EOSedge	Eos Imaging	2024-08-06
K233530	EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)	DRTECH Corporation	2024-07-26