K230800
- 510(k) number
- K230800
- Device name
- XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50
- Applicant
- GEMSS HEALTHCARE CO., LTD. KR
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2023-11-02
- Date received
- 2023-03-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K230800.pdf
Official FDA record: K230800
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.