K260716
- 510(k) number
- K260716
- Device name
- Neowise
- Applicant
- Cefla S.C. IT
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2026-05-04
- Date received
- 2026-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K260716.pdf
Official FDA record: K260716
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.