# K110020: Terason T3200 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Teratech Corp.
- Decided: Jan 20, 2011 after 17 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K934041 (1994). 21 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080234: Terason Echo T/3000 Ultrasound System with Stress Echo, Teratech Corp. (2008) Summary page 1.

## Most influential descendants
- K173703: Sonata Sonography-Guided Transcervical Fibroid Ablation System (2018), 6 descendants of its own
- K193516: Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 (2020), 5 descendants of its own
- K211535: Sonata Transcervical Fibroid Ablation System 2.2 (2021), 4 descendants of its own
- K131209: Terason USMART3200T Ultrasound System (2013), 4 descendants of its own
- K222304: Sonata Transcervical Fibroid Ablation System 2.2 (2022), 3 descendants of its own

## Indications for use
The subject-modified device is a general purpose Ultrasound System intended for use by a qualified phiysician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal: Abdominal; Intro-operative (abdominal, thoracic and PV): Laparosopic; Pediatric: Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Trans-rectal and Trans-vaginal: Musculo-skeletal Conventional and Superficial; Cardiac (adult & pediatic); Peripheral Vascular.

Source page: https://510kreport.com/device/K110020
Methodology: https://510kreport.com/methodology