# K233955: Clarius OB AI

- Pathway: 510(k) (Traditional)
- Applicant: Clarius Mobile Health Corp.
- Decided: Jun 14, 2024 after 182 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K935595 (1995). 128 ancestors in all.
No later device cites it as a predicate yet.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230365: Sonio Detect, Sonio (2023) Summary page 5.

## Indications for use
Clarius OB AI is intended to assist in measurements of fetal biometric parameters (i.e., head circumference, abdominal circumference, femur length, bi-parietal diameter, crown rump length) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear scanner). 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 GB Al is indicated for use in adult patients only.

Source page: https://510kreport.com/device/K233955
Methodology: https://510kreport.com/methodology