K252086
- 510(k) number
- K252086
- Device name
- DTX Studio Assist
- Applicant
- Nobel Biocare C/O Medicim NV BE
- Product code
- MYN — Analyzer, Medical Image
- Decision date
- 2025-11-17
- Date received
- 2025-07-02
- 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: K252086.pdf
Official FDA record: K252086
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.