K252353
- 510(k) number
- K252353
- Device name
- myray ProXIma X6
- Applicant
- Cefla S.C. IT
- Product code
- OAS — X-Ray, Tomography, Computed, Dental
- Decision date
- 2026-03-10
- Date received
- 2025-07-29
- 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: K252353.pdf
Official FDA record: K252353
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.