Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)— 510(k) K253628

Name: FDA 510(k) clearance K253628
Creator: U.S. Food and Drug Administration
Published: 2026-06-29

Substantially Equivalent

Agada Medical, Ltd.

FDA 510(k) clearance K253628 for Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012), Substantially Equivalent on 2026-06-29. Applicant: Agada Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Agada Medical, Ltd.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-11-19
Decision date: 2026-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramat-Hasharon, IL

Download summary PDF View on FDA.gov ↗

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