K260785
- 510(k) number
- K260785
- Device name
- DS Core CBCT Anatomy
- Applicant
- Dentsply Sirona PA · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-04-23
- Date received
- 2026-03-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K260785.pdf
Official FDA record: K260785
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.