K251642
- 510(k) number
- K251642
- Device name
- Dental CBCT X-ray System
- Applicant
- Yian Medical Technology (Haining) Co., Ltd. CN
- Product code
- OAS — X-Ray, Tomography, Computed, Dental
- Decision date
- 2025-06-27
- Date received
- 2025-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K251642.pdf
Official FDA record: K251642
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.