# K192107: Clarius Ultrasound Scanner

- Pathway: 510(k) (Abbreviated)
- Applicant: Clarius Mobile Health Corp.
- Decided: Aug 29, 2019 after 24 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: 25 generations back to K935595 (1995). 323 ancestors in all.
10 later devices descend from it; 7 cite it directly.
6 of 334 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180799: Clarius Ultrasound Scanner, Clarius Mobile Health Corp. (2018) Summary page 4.

## Most influential descendants
- K213436: Clarius Ultrasound Scanner (2021), 2 descendants of its own
- K211746: Pocket Ultrasound System (2022), 1 descendant of its own
- K231930: Digital Ultrasonic Diagnostic Imaging System (Model: F6) (2024), 0 descendants of its own
- K231509: Aco Apache Ultrasound System (2023), 0 descendants of its own
- K232704: Clarius Ultrasound Scanner (2023), 0 descendants of its own

## 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/K192107
Methodology: https://510kreport.com/methodology