# K232704: Clarius Ultrasound Scanner

- Pathway: 510(k) (Special)
- Applicant: Clarius Mobile Health Corp.
- Decided: Oct 5, 2023 after 30 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: 27 generations back to K935595 (1995). 325 ancestors in all.
No later device cites it as a predicate yet.
6 of 326 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213436: Clarius Ultrasound Scanner, Clarius Mobile Health Corp. (2021) Summary page 4.

## Indications for use
The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body. The system is a transportable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.

Source page: https://510kreport.com/device/K232704
Methodology: https://510kreport.com/methodology