# K152396: S12 Digital Color Doppler Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Sonoscape Medical Corp.
- Decided: Sep 3, 2015 after 10 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: 17 generations back to K935595 (1995). 129 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142474: S12 Digital Color Doppler Ultrasound System, Sonoscape Company Limited (2014) Summary page 23.

## Most influential descendants
- K170078: Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley (2017), 0 descendants of its own

## Indications for use
The SonoScape S12 system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Source page: https://510kreport.com/device/K152396
Methodology: https://510kreport.com/methodology