# K170085: SONON Ultrasound Imaging System, Model: 300L

- Pathway: 510(k) (Traditional)
- Applicant: Healcerion Co., Ltd.
- Decided: Oct 12, 2017 after 275 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.
4 later devices descend from it; 3 cite it directly.
6 of 217 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.
- K163138: Clarius Ultrasound System, Clarius Mobile Health Corp. (2016) Summary page 5.

## Most influential descendants
- K210468: SC1 Handheld Ultrasound Imaging System (Model: SC1) (2021), 1 descendant of its own
- K233579: SC1 Handheld Ultrasound Imaging system (Model: SC1) (2024), 0 descendants of its own
- K220169: SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) (2022), 0 descendants of its own
- K212400: SONON Ultrasound Imaging System, Model: SONON 500L (2022), 0 descendants of its own

## Indications for use
The SONON Ultrasound Imaging System (Model: 300L) is intended for diagnostic ultrasound echo imaging, measurement, and analysis of the human body for general clinical applications including musculoskeletal (MSK), vascular, small parts (breast, thyroid), and thoracic/pleural motion and fluid detection imaging.

Source page: https://510kreport.com/device/K170085
Methodology: https://510kreport.com/methodology