# K232501: AI Platform (AIP001)

- Pathway: 510(k) (Traditional)
- Applicant: Exo, Inc.
- Decided: Nov 17, 2023 after 92 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: 16 generations back to K935595 (1995). 113 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210053: LVivo Software Application, Dia Imaging Analysis, Ltd. (2021) Summary page 4.

## Most influential descendants
- K252007: BlineSlide (2025), 0 descendants of its own

## Indications for use
The AI Platform is intended for noninvasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of adult patients with suspected disease. The device is intended to be used on images from adult patients.

Source page: https://510kreport.com/device/K232501
Methodology: https://510kreport.com/methodology