K260192
- 510(k) number
- K260192
- Device name
- DIANA
- Applicant
- ROPCA ApS DK
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-07-24
- Date received
- 2026-01-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260192.pdf
Official FDA record: K260192
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.