K250947
- 510(k) number
- K250947
- Device name
- VistaSoft 4.0 and VisionX 4.0
- Applicant
- Durr Dental SE DE
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-08-27
- Date received
- 2025-03-28
- 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: K250947.pdf
Official FDA record: K250947
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.