# K261677: Artificial Intelligence Renal Assessment (AIRA) Version 1

- Pathway: 510(k) (Traditional)
- Applicant: Aramis Global AI Consultancies, LLC
- Decided: Sep 15, 2026 after 117 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: 11 generations back to K924630 (1993). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222676: Ceevra Reveal 3, Ceevra, Inc. (2023) Summary page 6.

## Indications for use
Non-invasive processing of CT kidney images using automatic image segmentation and measurement of anatomical structures utilizing artificial intelligence/machine-learning algorithms. The system automatically calculates the renal parenchymal volume. AIRA is intended for adult patients who require volumetric measurement of the kidneys for further clinical assessment.

Source page: https://510kreport.com/device/K261677
Methodology: https://510kreport.com/methodology