AiORTA - Plan— 510(k) K250337

Substantially Equivalent

ViTAA Medical Solutions, Inc.

FDA 510(k) clearance K250337 for AiORTA - Plan, Substantially Equivalent on 2025-10-30. Applicant: ViTAA Medical Solutions, Inc.. Device class: 2.

Clearance details

Applicant: ViTAA Medical Solutions, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-02-06
Decision date: 2025-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

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More clearances from ViTAA Medical Solutions, Inc.

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Data sourced from openFDA. This site is unofficial and independent of the FDA.