K242478
- 510(k) number
- K242478
- Device name
- GF85 (models GF85-3P, GF85-SP)
- Applicant
- Samsung Electronics Co., Ltd. KR
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2024-09-19
- Date received
- 2024-08-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K242478.pdf
Official FDA record: K242478
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.