K260481
- 510(k) number
- K260481
- Device name
- GC85A
- Applicant
- Samsung Electronics Co., Ltd. KR
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2026-08-27
- Date received
- 2026-02-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K260481.pdf
Official FDA record: K260481
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.