K251038
- 510(k) number
- K251038
- Device name
- Digital Radiographic Imaging Acquisition Software - DR (RiasDR)
- Applicant
- Shen Zhen Cambridge-Hit Co., Ltd. CN
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-08-06
- Date received
- 2025-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K251038.pdf
Official FDA record: K251038
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.