K250755
- 510(k) number
- K250755
- Device name
- DS Core Diagnosis
- Applicant
- Dentsply Sirona, Inc. PA · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-08-12
- Date received
- 2025-03-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250755.pdf
Official FDA record: K250755
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.