# K150533: Terason uSmart3200T Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Teratech Corp.
- Decided: May 9, 2015 after 68 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: 16 generations back to K935595 (1995). 146 ancestors in all.
2 later devices descend from it; 1 cites it directly.
6 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140524: Terason USMART3200 and Benq UP200ULTRASOUND System, Teratech Corp. (2014) Summary page 16.
- K112953: Terason T3000 Ultrasound Systems with Updated Needle Guidance Graphics, Teratech Corp. (2012) Summary page 13.
- K132304: Epiq Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2013) Summary page 16.
- K070792: Qlab Quantification, Philips Ultrasound, Inc. (2007) Summary page 21.
- K110482: Prosound C3 / C3 CV Ultrasound Systems, Teratech Corp. (2011) Summary page 16.
- K140773: Terason USMART3300 Ultrasound System, Teratech Corp. (2014) Summary page 4.
- K082098: Sonosite Maxx Series Ultrasound System, Sonosite,Inc. (2008) Summary page 16.

## Cited in the summary but kept off the family tree
- K071792: Sonosite Maxx. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 19.

## Most influential descendants
- 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 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: Ophthalmic, Fetal, Abdominal, Intra-operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-cardiac), Musculo-skeletal (Conventional and Superficial), Cardiac (Adult & Pediatric), Trans-esophageal (cardiac), and Peripheral Vascular.

Source page: https://510kreport.com/device/K150533
Methodology: https://510kreport.com/methodology