# K172380: U2 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Sep 29, 2017 after 53 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: 20 generations back to K935595 (1995). 127 ancestors in all.
No later device cites it as a predicate yet.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142511: U50 Diagnostic Ultrasound System, Edan Instruments, Inc. (2015) Summary page 16.

## Indications for use
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K172380
Methodology: https://510kreport.com/methodology