K253969
- 510(k) number
- K253969
- Device name
- ADAS 3D
- Applicant
- Adas3D Medical S.L. ES
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-06-29
- Date received
- 2025-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K253969.pdf
Official FDA record: K253969
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.