K261500
- 510(k) number
- K261500
- Device name
- KBA3D (v2.4.0)
- Applicant
- S.M.A.I.O FR
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2026-08-17
- Date received
- 2026-05-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K261500.pdf
Official FDA record: K261500
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.