# K233579: SC1 Handheld Ultrasound Imaging system (Model: SC1)

- Pathway: 510(k) (Special)
- Applicant: Fcu Co., Ltd.
- Decided: Jun 26, 2024 after 232 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: 21 generations back to K935595 (1995). 214 ancestors in all.
No later device cites it as a predicate yet.
6 of 215 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210468: SC1 Handheld Ultrasound Imaging System (Model: SC1), Fcu Co., Ltd. (2021) Summary page 5.

## Indications for use
The SC1 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. Flow detection is possible using PWD (Power Doppler) mode. SC1 is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

Source page: https://510kreport.com/device/K233579
Methodology: https://510kreport.com/methodology