Data / Medical devices / South Korea / Samsung Electronics Co., Ltd.
Samsung Electronics Co., Ltd.: FDA-registered device maker in Suwon-si Gyeonggi, South Korea, 19 510(k) clearances
Samsung Electronics Co., Ltd. is registered with the FDA (registration 3010300212) in Suwon-si Gyeonggi, South Korea. It lists 4 device types. The FDA files 19 510(k) clearances under its listings, the newest dated August 27, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3010300212
- Address
- 129, Samsung-ro, Yeongtong-gu, Suwon-si Gyeonggi, South Korea, 16677
- Owner or operator
- Samsung Electronics Co., Ltd. (10043488)
- Roles
- Manufacturer
- First device listed
- June 2, 2014
- Registered through
- 2026
- Brand names listed
- ALND; Auto Lung Nodule Detection, AccE GC85A, AccE GC85A; GC85A; GC85A with Prestige, AccE GF85, AccE GM85; GM85; GM85 with Lite; GM85 with Prestige, AccE GM85; GM85; GM85 with Lite; GM85 with Prestige: GM85 Elite, GC85A, GC85A with Prestige and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Medical Image | MYN | 2 | Manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 27, 2026 | K260481 | GC85A | KPR | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| October 1, 2024 | K242651 | GM85 | IZL | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| September 19, 2024 | K242478 | GF85 (models GF85-3P, GF85-SP) | KPR | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| September 29, 2022 | K222353 | GM85 | IZL | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| April 21, 2022 | K220175 | GM85 | IZL | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| August 31, 2021 | K201560 | Auto Lung Nodule Detection | MYN | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| December 7, 2018 | K182183 | GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A | KPR | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| July 20, 2018 | K181631 | GR40CW | MQB | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| July 20, 2018 | K181629 | GC85A | KPR | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| July 20, 2018 | K181626 | Digital Diagnostic Mobile X-ray System | IZL | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| May 24, 2018 | K180543 | GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 | KPR | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| November 22, 2017 | K172229 | GC85A | KPR | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| May 12, 2017 | K171119 | GM85 | IZL | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| November 15, 2016 | K162278 | Digital Diagnostic Mobile X-ray System | IZL | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| July 6, 2016 | K160997 | GC85A | KPR | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| December 21, 2015 | K153401 | GR40CW | MQB | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| October 16, 2015 | K152094 | GR40CW | MQB | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| April 2, 2015 | K150165 | GC85A | KPR | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
| May 15, 2014 | K140235 | XGEO GR40CW | MQB | Substantially Equivalent | Samsung Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Medical Image
- All makers of System, X-Ray, Stationary
- All makers of System, X-Ray, Mobile
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
Updated August 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.