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FDA 510(k)

AiORTA - Plan

K-Number: K250337 · 2025-10-30

ApplicantViTAA Medical Solutions, Inc.
Decision Date2025-10-30
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AiORTA - Plan is a medical device manufactured by ViTAA Medical Solutions, Inc.. It received FDA 510(k) clearance on 2025-10-30 under approval number K250337. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AiORTA - Plan?

AiORTA - Plan is a medical device that received FDA 510(k) clearance on 2025-10-30. It is manufactured by ViTAA Medical Solutions, Inc.. The 510(k) number is K250337.

When was AiORTA - Plan approved by the FDA?

AiORTA - Plan received FDA 510(k) clearance on 2025-10-30, under approval number K250337.

What company makes AiORTA - Plan?

AiORTA - Plan is manufactured by ViTAA Medical Solutions, Inc..

What is the FDA product code for AiORTA - Plan?

The FDA product code for AiORTA - Plan is QIH.

Other Devices by ViTAA Medical Solutions, Inc.

K254207AiORTA - Plan v2.0

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Official Source

View on FDA Database →

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