# K212400: SONON Ultrasound Imaging System, Model: SONON 500L

- Pathway: 510(k) (Traditional)
- Applicant: Healcerion Co., Ltd.
- Decided: Apr 22, 2022 after 263 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). 325 ancestors in all.
No later device cites it as a predicate yet.
6 of 326 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192107: Clarius Ultrasound Scanner, Clarius Mobile Health Corp. (2019) Summary page 4.
- K170085: SONON Ultrasound Imaging System, Model: 300L, Healcerion Co., Ltd. (2017) Summary page 5.

## Indications for use
The SONON Ultrasound Imaging System (Model: SONON 500L) 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 thorax (thoracic/pleural motion and fluid detection imaging). SONON 500L provides 4 modes: B (2D) mode, CF (Color Flow) mode, PW (Pulsed Wave) mode, M (Motion) mode. SONON 500L is suitable for use in professional healthcare environment (hospital, clinic and medical office settings) by appropriately trained healthcare professional.

Source page: https://510kreport.com/device/K212400
Methodology: https://510kreport.com/methodology