# K250337: AiORTA - Plan

- Pathway: 510(k) (Traditional)
- Applicant: ViTAA Medical Solutions, Inc.
- Decided: Oct 30, 2025 after 266 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: 9 generations back to K913770 (1991). 67 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191585: iNtuition-Structural Heart Module, Terarecon,Inc. (2019) Summary page 5.

## Most influential descendants
- K254207: AiORTA - Plan v2.0 (2026), 0 descendants of its own

## Indications for use
The AiORTA - Plan tool is an image analysis software tool for volumetric assessment. 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/K250337
Methodology: https://510kreport.com/methodology