# K112602: S6 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscape Company Limited
- Decided: Nov 7, 2011 after 61 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
No predicates in its family tree.
36 later devices descend from it; 5 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K1110510: S20 Digital Doppler Ultrasound System and Transducers. Number could not be read

## Most influential descendants
- K131088: Portable Digital Color Doppler Ultrasound System (2013), 32 descendants of its own
- K132768: S8 Exp Portable Digital Color Doppler Ultrasound System (2013), 30 descendants of its own
- K142710: S9 Portable Digital Color Doppler Ultrasound System (2015), 19 descendants of its own
- K131213: Digital Color Doppler Ultrasound System (2013), 18 descendants of its own
- K150045: S30/S40 Digital Color Doppler Ultraound System (2015), 17 descendants of its own

## Indications for use
The SonoScape S6 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, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

Source page: https://510kreport.com/device/K112602
Methodology: https://510kreport.com/methodology