# K160258: X5 Digital Color Doppler Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscape Medical Corp.
- Decided: Apr 1, 2016 after 60 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: 21 generations back to K935595 (1995). 208 ancestors in all.
2 later devices descend from it; 2 cite it directly.
6 of 211 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152164: S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System, Sonoscape Medical Corp. (2015) Summary page 13.

## Most influential descendants
- K170303: E5 Series Digital Color Doppler Ultrasound System (2017), 0 descendants of its own
- K163427: X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System (2017), 0 descendants of its own

## Indications for use
The SonoScape X5 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), OB/Gyn and Urology.

Source page: https://510kreport.com/device/K160258
Methodology: https://510kreport.com/methodology