# K210468: SC1 Handheld Ultrasound Imaging System (Model: SC1)

- Pathway: 510(k) (Traditional)
- Applicant: Fcu Co., Ltd.
- Decided: Jul 23, 2021 after 157 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: 20 generations back to K935595 (1995). 213 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 215 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170085: SONON Ultrasound Imaging System, Model: 300L, Healcerion Co., Ltd. (2017) Summary page 5.

## Most influential descendants
- K233579: SC1 Handheld Ultrasound Imaging system (Model: SC1) (2024), 0 descendants of its own

## Indications for use
The SC1 Handheld Ultrasound Imaging System (Model: SC1) 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) through B mode. SC1 is a transportable ultrasound system intended for use in environments where healthcare is provided by appropriately trained healthcare professionals.

Source page: https://510kreport.com/device/K210468
Methodology: https://510kreport.com/methodology