AiORTA - Plan v2.0— 510(k) K254207

Substantially Equivalent

ViTAA Medical Solutions, Inc.

FDA 510(k) clearance K254207 for AiORTA - Plan v2.0, Substantially Equivalent on 2026-03-30. Applicant: ViTAA Medical Solutions, Inc..

Clearance details

Applicant: ViTAA Medical Solutions, Inc.
Product code: Code QIH
Advisory panel: Radiology
Date received: 2025-12-29
Decision date: 2026-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

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