KBA3D (v2.4.0)— 510(k) K261500
Substantially EquivalentS.M.A.I.O
FDA 510(k) clearance K261500 for KBA3D (v2.4.0), Substantially Equivalent on 2026-08-17. Applicant: S.M.A.I.O. Device class: 2.
Summary
S.M.A.I.O's KBA3D, version 2.4.0, is filed under product code LLZ, radiological image processing systems. The record doesn't expand the name or describe the product further.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. The submission was a Traditional 510(k).
The applicant filed from Saint-Priest, France. Review took 103 calendar days (May 6 to August 17, 2026) and ended in a substantially equivalent decision.
Clearance details
- Applicant
- S.M.A.I.O
- Product code
- Product code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saint-Priest, FR
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Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.