ADAS 3D— 510(k) K253969

Substantially Equivalent

Adas3D Medical S.L.

FDA 510(k) clearance K253969 for ADAS 3D, Substantially Equivalent on 2026-06-29. Applicant: Adas3D Medical S.L.. Device class: 2.

Clearance details

Applicant: Adas3D Medical S.L.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-12-11
Decision date: 2026-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

Download summary PDF View on FDA.gov ↗

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