# K080234: Terason Echo T/3000 Ultrasound System with Stress Echo

- Pathway: 510(k) (Traditional)
- Applicant: Teratech Corp.
- Decided: Feb 14, 2008 after 15 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K934041 (1994). 20 ancestors in all.
84 later devices descend from it; 3 cite it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021497: Cypress Ultrasound System, Acuson Corp. (2002) Summary page 1.
- K022567: Sequoia Signature II Diagnostic Ultrasound System, Acuson Corp. (2002) Summary page 1.

## Most influential descendants
- K112953: Terason T3000 Ultrasound Systems with Updated Needle Guidance Graphics (2012), 74 descendants of its own
- K130173: Sonosite Maxx Series Ultrasound System (2013), 52 descendants of its own
- K133454: Sonosite Edge Ultrasound System (2013), 50 descendants of its own
- K142017: X-Porte Ultrasound System (2014), 46 descendants of its own
- K152209: FUJIFILM SonoSite X-Porte Ultrasound System (2015), 45 descendants of its own

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K080234
Methodology: https://510kreport.com/methodology