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FDA-cleared K254207

AiORTA - Plan v2.0

ViTAA Medical Solutions, Inc.

Authorized purpose: AiORTA - Plan v2.0 is image-processing and analysis software for the labeled radiotherapy-planning workflow; exact modalities, structures, inputs, outputs, and user-review requirements remain submission-specific.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region
Decision
2026-03-30
FDA-cleared K250337

AiORTA - Plan

ViTAA Medical Solutions, Inc.

Authorized purpose: AiORTA Plan analyzes cardiovascular CT angiography data to provide volumetric visualization and measurements as adjunctive information for licensed healthcare professionals; it is not intended to be the sole basis for treatment or patient management.

Modality
CT/CTA
Anatomy
Aorta and cardiovascular structures
Decision
2025-10-30