# K232257: Clarius Bladder AI

- Pathway: 510(k) (Traditional)
- Applicant: Clarius Mobile Health Corp.
- Decided: Nov 13, 2023 after 108 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: 2 generations back to K203502 (2021). 2 ancestors in all.
1 later device descends 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)
- K230497: Bladder AI (AIBV01), Exo, Inc. (2023) Summary page 4.

## Most influential descendants
- K243853: Clarius Prostate AI (2025), 0 descendants of its own

## Indications for use
Clarius Bladder AI is intended for semi-automatic non-invasive measurements of bladder volume on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear and phased array scanners). The user shall be a healthcare professional trained and qualified in ultrasound. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment. Clarius Bladder AI is indicated for use in adult patients only.

Source page: https://510kreport.com/device/K232257
Methodology: https://510kreport.com/methodology