# K211665: SONON Ultrasound Imaging System, Model: SONON300C

- Pathway: 510(k) (Special)
- Applicant: Healcerion Co., Ltd.
- Decided: May 16, 2022 after 349 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: 26 generations back to K935595 (1995). 324 ancestors in all.
No later device cites it as a predicate yet.
6 of 325 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151339: SONON Ultrasound Imaging System (Model: SONON 300C), Healcerion Co., Ltd. (2015) Summary page 5.
- K192107: Clarius Ultrasound Scanner, Clarius Mobile Health Corp. (2019) Summary page 5.

## Indications for use
The SONON Ultrasound Imaging System (Model: SONON 300C) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including obstetrics (OB), gynecology (GY) and general (abdominal) imaging. The system operating modes is B (Brightness), CF (color flow), PW (pulsed wave), M (motion). The intended to be used in a hospital or medical clinic is used by appropriately trained healthcare professionals, including radiologists, sonographers, technologists, and clinicians, in a medical facility.

Source page: https://510kreport.com/device/K211665
Methodology: https://510kreport.com/methodology