K251078
- 510(k) number
- K251078
- Device name
- AutoDensity
- Applicant
- Eos Imaging FR
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-11-14
- Date received
- 2025-04-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251078.pdf
Official FDA record: K251078
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.