# K131209: Terason USMART3200T Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Teratech Corp.
- Decided: May 24, 2013 after 25 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.
4 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K140524: Terason USMART3200 and Benq UP200ULTRASOUND System (2014), 3 descendants of its own
- K150533: Terason uSmart3200T Ultrasound System (2015), 2 descendants of its own
- K193510: Terason uSmart3200T Ultrasound System (2020), 1 descendant of its own
- K201633: Terason uSmart 3200T Plus Ultrasound System (2020), 0 descendants of its own

## Indications for use
The Teratech Corporation Terason™ uSmart3200T (also known as the BenQ UP200) 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, Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.

Source page: https://510kreport.com/device/K131209
Methodology: https://510kreport.com/methodology