# K130801: Digital Color Doppler Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscape Company Limited
- Decided: Jun 14, 2013 after 84 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: 1 generation back to K112602 (2011). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112602: S6 Diagnostic Ultrasound System, Sonoscape Company Limited (2011) Summary page 1.

## 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 S11 device 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, Transvaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neconatal and adult), OB/Gyn and Urology.

Source page: https://510kreport.com/device/K130801
Methodology: https://510kreport.com/methodology