# K121867: Sonotouch Series Diagnostic Ultrasound Systems

- Pathway: 510(k) (Traditional)
- Applicant: Chison Medical Imaging Co., Ltd.
- Decided: Aug 2, 2012 after 37 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: 10 generations back to K863700 (1987). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102256: GE Logiq I/E & Vivid E Compact Diagnostic Ultrasound, Ge Medical Systems China Co., Ltd. (2010) Summary page 1.

## Most influential descendants
- K170870: Site~Rite Halcyon Diagnostic Ultrasound System (2017), 0 descendants of its own

## Indications for use
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.

Source page: https://510kreport.com/device/K121867
Methodology: https://510kreport.com/methodology