# K132527: Digital Color Doppler Ultasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscape Company Limited
- Decided: Nov 14, 2013 after 94 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: 18 generations back to K935595 (1995). 120 ancestors in all.
28 later devices descend from it; 4 cite it directly.
0 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102642: Sonoscape Ultrasound System and Transducers Model Ssi-8000, 2P1 Phased Array, 5P1 Phased Array Model 2P1, 5P1, 6V1 Micro, Sonoscape Company Limited (2011) Summary page 1.

## Most influential descendants
- K142710: S9 Portable Digital Color Doppler Ultrasound System (2015), 19 descendants of its own
- K150045: S30/S40 Digital Color Doppler Ultraound System (2015), 17 descendants of its own
- K152854: S50 Digital Color Doppler Ultrasound System (2016), 16 descendants of its own
- K160283: S45 Digital Color Doppler Ultrasound System (2016), 15 descendants of its own
- K172082: S60 Series Digital Color Doppler Ultrasound System (2017), 5 descendants of its own

## Indications for use
The SonoScape S30 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. Trans-esoph (Cardiac). Peripheral Vascular. Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Urology and OB/Gyn.

Source page: https://510kreport.com/device/K132527
Methodology: https://510kreport.com/methodology