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.

Summary

Agada Medical's clearance names Auto-Seg and Spine Auto-Seg, both with the model number SO-0012. They're filed under QIH, automated radiological image processing software, and the record doesn't say how the two names relate.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).

Agada filed from Ramat-Hasharon, Israel. The decision came 222 calendar days after receipt (November 19, 2025 to June 29, 2026).

Clearance details

Applicant: Agada Medical, Ltd.
Product code: Product 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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