510(k) K182183
- Device
- GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A
- Applicant
- Samsung Electronics Co., LTD.
- 510(k) number
- K182183
- Product code
- KPR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-12-07
- Date received
- 2018-08-13
- 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
- No
Applicant Contact#
- Contact
- Jaesang Noh
- Address
- 129 Samsung-Ro, Yeongtong-Gu Suwon-Si KR 16677 16677
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#
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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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