# K260217: AI Platform 2.2 (AIP002)

- Pathway: 510(k) (Special)
- Applicant: Exo Imaging
- Decided: Feb 24, 2026 after 32 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: 18 generations back to K935595 (1995). 115 ancestors in all.
No later device cites it as a predicate yet.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240953: AI Platform 2.0 (AIP002), Exo Imaging (2024) Summary page 5.

## Indications for use
AI Platform 2.2 is intended for noninvasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease. In addition, it can provide Quality Score feedback to assist healthcare professionals, trained and qualified to conduct echocardiography, abdominal, and lung ultrasound scans in the current standard of care while acquiring ultrasound images. The device is intended to be used on images of adult patients.

Source page: https://510kreport.com/device/K260217
Methodology: https://510kreport.com/methodology