Medical Device Manufacturer · US , Aubrey , TX

Samsung Sds Co., Ltd. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1999

Recent clearances: RAYPAX WEB CLINICAL SYSTEM, SAMSUNG RAYPAX DISPLAY WORKSTATION, SAMSUNG RAYPAX LONG TERM ARCHIVE

6
Total
6
Cleared
0
Denied

Samsung Sds Co., Ltd. is an enterprise IT solutions provider with a manufacturing facility in Aubrey, US. The company has developed medical imaging and archival systems for healthcare organizations.

Samsung Sds received 6 FDA 510(k) clearances from 6 total submissions, with all submissions focused on Radiology devices. The company's regulatory activity spans from 1999 to 2000. This represents a historical record; no clearances have been granted in more than two decades.

The company's cleared portfolio includes imaging workstations, long-term archival systems, film digitizers, and implant systems. These products supported clinical workflows in radiology departments during the early digital transition in medical imaging.

Explore the complete list of device names, product codes, and clearance dates in the database.

FDA 510(k) Regulatory Record - Samsung Sds Co., Ltd.

6 devices
1-6 of 6
Filters
All6 Radiology 6