# K254207: AiORTA - Plan v2.0

- Pathway: 510(k) (Traditional)
- Applicant: ViTAA Medical Solutions, Inc.
- Decided: Mar 30, 2026 after 91 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K913770 (1991). 68 ancestors in all.
No later device cites it as a predicate yet.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250337: AiORTA - Plan, ViTAA Medical Solutions, Inc. (2025) Summary page 5.

## Indications for use
The AiORTA - Plan tool is an image analysis software tool for volumetric assessment, image analysis, geometric analysis, and pre-operative sizing and planning. It provides volumetric visualization and measurements based on 3D reconstruction computed from cardiovascular CTA scans. The software device is intended to provide adjunct information to a licensed healthcare practitioner (HCP) in addition to clinical data and other inputs, as a measurement tool used in assessment of aortic aneurysm, pre-operative evaluation, planning and sizing for cardiovascular intervention and surgery, and for post-operative evaluation in patients 22 years old and older. The device is not intended to provide stand-alone diagnosis or suggest an immediate course of action in treatment or patient management

Source page: https://510kreport.com/device/K254207
Methodology: https://510kreport.com/methodology