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FDA 510(k)

AiORTA - Plan v2.0

K-Number: K254207 · 2026-03-30

ApplicantViTAA Medical Solutions, Inc.
Decision Date2026-03-30
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AiORTA - Plan v2.0 is a medical device manufactured by ViTAA Medical Solutions, Inc.. It received FDA 510(k) clearance on 2026-03-30 under approval number K254207. 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 v2.0?

AiORTA - Plan v2.0 is a medical device that received FDA 510(k) clearance on 2026-03-30. It is manufactured by ViTAA Medical Solutions, Inc.. The 510(k) number is K254207.

When was AiORTA - Plan v2.0 approved by the FDA?

AiORTA - Plan v2.0 received FDA 510(k) clearance on 2026-03-30, under approval number K254207.

What company makes AiORTA - Plan v2.0?

AiORTA - Plan v2.0 is manufactured by ViTAA Medical Solutions, Inc..

What is the FDA product code for AiORTA - Plan v2.0?

The FDA product code for AiORTA - Plan v2.0 is QIH.

Other Devices by ViTAA Medical Solutions, Inc.

K250337AiORTA - Plan

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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