510(k) clearance
KBA3D (v2.4.0)
- 510(k) number
- K261500
- Applicant
- S.M.A.I.O
- Decision date
- Aug 17, 2026
- Date received
- May 6, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- LLZ
- Device type
- System, Image Processing, Radiological
- Device class
- Class II
- Regulation
- 21 CFR 892.2050
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Saint-Priest, FR