# K150148: Terason uSmart3300 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Teratech Corp.
- Decided: Feb 20, 2015 after 28 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). 143 ancestors in all.
No later device cites it as a predicate yet.
6 of 144 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140773: Terason USMART3300 Ultrasound System, Teratech Corp. (2014) Summary page 4.
- K071134: Sonosite Maxx Series Diagnostic Ultrasound System, Sonosite,Inc. (2007) Summary page 16.
- K112953: Terason T3000 Ultrasound Systems with Updated Needle Guidance Graphics, Teratech Corp. (2012) Summary page 10.
- K132304: Epiq Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2013) Summary page 16.
- K070792: Qlab Quantification, Philips Ultrasound, Inc. (2007) Summary page 16.
- K110482: Prosound C3 / C3 CV Ultrasound Systems, Teratech Corp. (2011) Summary page 16.
- K082098: Sonosite Maxx Series Ultrasound System, Sonosite,Inc. (2008) Summary page 16.

## Indications for use
The Teratech Corporation Terason uSmart3300 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-esoph. (non-cardiac), Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esoph. (cardiac) Peripheral Vascular.

Source page: https://510kreport.com/device/K150148
Methodology: https://510kreport.com/methodology