# K151339: SONON Ultrasound Imaging System (Model: SONON 300C)

- Pathway: 510(k) (Traditional)
- Applicant: Healcerion Co., Ltd.
- Decided: Sep 10, 2015 after 114 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K935595 (1995). 96 ancestors in all.
33 later devices descend from it; 5 cite it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102153: Mobius Ultrasound Imaging System, Mobisante, Inc. (2011) Summary page 5.
- K100598: Penrith Elettra Ultrasound System, Penrith Corporation (2010) Summary page 5.

## Most influential descendants
- K163138: Clarius Ultrasound System (2016), 28 descendants of its own
- K172385: Clarius Ultrasound System (2017), 22 descendants of its own
- 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

## 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.

Source page: https://510kreport.com/device/K151339
Methodology: https://510kreport.com/methodology