# K131973: Unexef-38G Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Toyota Tsusho Corporation
- Decided: Nov 18, 2014 after 508 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: 4 generations back to K003525 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110920: UF-760AG, Fukuda Denshi Co., Ltd. (2011) Summary page 6.
- K081919: UF-870 AG Diagnostic Ultrasound System, Fukuda Denshi Co., Ltd. (2008) Summary page 6.

## Indications for use
The system is intended for use by a qualified physician for diagnostic ultrasound imaging or fluid flow analysis of the human body in Peripheral Vascular vessels. The UNEXEF38G ultrasound instrument is intended to perform the following diagnostic ultrasound investigations: Imaging (A/B-Mode), Color Flow Doppler (CFD), and provides calculations of Flow mediated dilation measurements during reactive hyperemia.

Source page: https://510kreport.com/device/K131973
Methodology: https://510kreport.com/methodology