# K193510: Terason uSmart3200T Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Teratech Corporation
- Decided: Jan 28, 2020 after 41 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: 17 generations back to K935595 (1995). 147 ancestors in all.
1 later device descends 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)
- K150533: Terason uSmart3200T Ultrasound System, Teratech Corp. (2015) Summary page 4.

## Most influential descendants
- K201633: Terason uSmart 3200T Plus Ultrasound System (2020), 0 descendants of its own

## Indications for use
The Teratech Corporation Terason™ uSmart3200T is a prescription-only, general-purpose Ultrasound System intended for use by a qualified physician or accredited sonographer for evaluation by ultrasound imaging or fluid flow analysis of the human body. The device is intended for use in a clinic, hospital or medical-emergency setting. 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/K193510
Methodology: https://510kreport.com/methodology