# K172385: Clarius Ultrasound System

- Pathway: 510(k) (Abbreviated)
- Applicant: Clarius Mobile Health Corp.
- Decided: Sep 14, 2017 after 37 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: 19 generations back to K935595 (1995). 212 ancestors in all.
22 later devices descend from it; 2 cite it directly.
6 of 235 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133454: Sonosite Edge Ultrasound System, FUJIFILM Sonosite, Inc. (2013) Summary page 10.
- K163138: Clarius Ultrasound System, Clarius Mobile Health Corp. (2016) Summary page 10.

## Most influential descendants
- K180799: Clarius Ultrasound Scanner (2018), 11 descendants of its own
- K192107: Clarius Ultrasound Scanner (2019), 10 descendants of its own
- K191235: Leltek Ultrasound Imaging System (2020), 9 descendants of its own
- K210432: LELTEK Ultrasound Imaging System (Model: LU700 Series) (2021), 8 descendants of its own
- K222365: Leltek Ultrasound Imaging System (Model: LU700 Series) (2022), 7 descendants of its own

## Indications for use
The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging in B-mode, M-mode, Color Doppler, Power Doppler, and Combined (B+M; B+Color Doppler; and B+Power Doppler). 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), musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), fetal echo, 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/K172385
Methodology: https://510kreport.com/methodology