K250716
- 510(k) number
- K250716
- Device name
- IMAGE ONE
- Applicant
- Infomed Software, S.L. ES
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-07-23
- Date received
- 2025-03-10
- 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: K250716.pdf
Official FDA record: K250716
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.