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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 the device name listed in this FDA 510(k) record. The listed applicant is ViTAA Medical Solutions, Inc.. It received FDA 510(k) clearance on 2026-03-30 under 510(k) 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. The listed applicant is ViTAA Medical Solutions, Inc.. The 510(k) number is K254207.

When did AiORTA - Plan v2.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for AiORTA - Plan v2.0?

The FDA 510(k) record lists ViTAA Medical Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing ViTAA Medical Solutions, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250337AiORTA - Plan

Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.

Official Source

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

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