# K243853: Clarius Prostate AI

- Pathway: 510(k) (Traditional)
- Applicant: Clarius Mobile Health Corp.
- Decided: Apr 16, 2025 after 121 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: 3 generations back to K203502 (2021). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232257: Clarius Bladder AI, Clarius Mobile Health Corp. (2023) Summary page 5.

## Indications for use
Clarius Prostate AI is intended for semi-automatic measurements of prostate volume on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear and endo-cavitary scanners). The user shall be a healthcare professional trained and qualified in ultrasound. The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius Prostate AI is intended for use in adult male patients only.

Source page: https://510kreport.com/device/K243853
Methodology: https://510kreport.com/methodology