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

Substantially Equivalent

Agada Medical, Ltd.

Clearance details

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

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