510(k) K250954

Device: DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
Applicant: Carestream Health
510(k) number: K250954
Product code: KPR
Decision: Substantially Equivalent (SESE)
Decision date: 2026-01-20
Date received: 2025-03-28
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: Gina Maiolo
Address: 150 Verona St. Rochester NY US 14608 14608

FDA Registration Numbers

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

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
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
K242019	GXR-Series Diagnostic X-Ray System	DRGEM Corporation	2025-01-07
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