# K170303: E5 Series Digital Color Doppler Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscape Medical Corp.
- Decided: May 19, 2017 after 108 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: 22 generations back to K935595 (1995). 209 ancestors in all.
No later device cites it as a predicate yet.
6 of 210 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160258: X5 Digital Color Doppler Ultrasound System, Sonoscape Medical Corp. (2016) Summary page 18.

## Indications for use
The SonoScape E5 Exp/E5/E5 Pro/E3 Exp/E3/E3 Pro/E2 Exp/E2/E2 Pro/E1 Exp/E1/E1 Pro Digital Color Doppler Ultrasound 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 (pediatric and adult), OB/Gyn and Urology.

Source page: https://510kreport.com/device/K170303
Methodology: https://510kreport.com/methodology