# K140834: Terason USMART3400 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Teratech Corp.
- Decided: Apr 25, 2014 after 23 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: 6 generations back to K934041 (1994). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110020: Terason T3200 Ultrasound System, Teratech Corp. (2011) Summary page 1.
- K112953: Terason T3000 Ultrasound Systems with Updated Needle Guidance Graphics, Teratech Corp. (2012) Summary page 1.

## Indications for use
The Teratech Corporation Terason™ uSmart3400 is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Pediatric, Small Organ (thyroid, breast, testes), Neonatal Cephalic, Adult Cephalic, Musculoskeletal (conventional and superficial), Cardiac (adult and pediatric), and Peripheral Vascular. Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K140834
Methodology: https://510kreport.com/methodology