# K201633: Terason uSmart 3200T Plus Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Teratech Corporation
- Decided: Jul 2, 2020 after 16 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: 18 generations back to K935595 (1995). 148 ancestors in all.
No later device cites it as a predicate yet.
6 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193510: Terason uSmart3200T Ultrasound System, Teratech Corporation (2020) Summary page 4.

## Indications for use
The Teratech Corporation Terason uSmart3200T Plus 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/K201633
Methodology: https://510kreport.com/methodology