# K112953: Terason T3000 Ultrasound Systems with Updated Needle Guidance Graphics

- Pathway: 510(k) (Traditional)
- Applicant: Teratech Corp.
- Decided: Feb 3, 2012 after 122 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: 5 generations back to K934041 (1994). 21 ancestors in all.
74 later devices descend from it; 7 cite it directly.
0 of 96 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
- 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
- K153626: SonoSite Edge II Ultrasound System (2016), 42 descendants of its own

## Indications for use
The subject-modified device is a general purpose Ultrasound System intended for use by a qualified physician for the evaluation by ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Intra-Operative (spec. and Neuro), Laparoscopic, Pediatric, Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-sketetal (Conventional and Superficial), Cardiac (adult and pediatric), and Peripheral Vascular.

Source page: https://510kreport.com/device/K112953
Methodology: https://510kreport.com/methodology