K242499
- 510(k) number
- K242499
- Device name
- Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))
- Applicant
- Shenzhen Sontu Medical Imaging Equipment Co., Ltd. CN
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2025-01-06
- Date received
- 2024-08-22
- 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: K242499.pdf
Official FDA record: K242499
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.