# K152165: S9 Portable Digital Color Doppler Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: Sonoscape Medical Corp.
- Decided: Aug 26, 2015 after 23 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K935595 (1995). 207 ancestors in all.
No later device cites it as a predicate yet.
6 of 208 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142710: S9 Portable Digital Color Doppler Ultrasound System, Sonoscape Company Limited (2015) Summary page 34.

## Recalls of this device
- Jul 9, 2014 · Class II · Z-2110-2014: The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.
- Jul 9, 2014 · Class II · Z-2109-2014: The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions.

## Indications for use
The SonoScape S9 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, Cerebral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.

Source page: https://510kreport.com/device/K152165
Methodology: https://510kreport.com/methodology