# K230497: Bladder AI (AIBV01)

- Pathway: 510(k) (Traditional)
- Applicant: Exo, Inc.
- Decided: Jun 22, 2023 after 118 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: 1 generation back to K203502 (2021). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203502: MEDO-Thyroid, Medo DX Pte., Ltd. (2021) Summary page 4.

## Most influential descendants
- K232257: Clarius Bladder AI (2023), 1 descendant of its own
- K243853: Clarius Prostate AI (2025), 0 descendants of its own

## Indications for use
Bladder Al uses machine-learning techniques to aid in the quantification of bladder volume from ultrasound images. The device is intended to be used on images of patients aged two years or older.

Source page: https://510kreport.com/device/K230497
Methodology: https://510kreport.com/methodology