# K110482: Prosound C3 / C3 CV Ultrasound Systems

- Pathway: 510(k) (Traditional)
- Applicant: Teratech Corp.
- Decided: Mar 18, 2011 after 28 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.
4 later devices descend from it; 2 cite it directly.
0 of 26 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
- K150533: Terason uSmart3200T Ultrasound System (2015), 2 descendants of its own
- K193510: Terason uSmart3200T Ultrasound System (2020), 1 descendant of its own
- K201633: Terason uSmart 3200T Plus Ultrasound System (2020), 0 descendants of its own
- K150148: Terason uSmart3300 Ultrasound System (2015), 0 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 evaluation by ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Intra-operative (abdominal, thoracic and PV); Laparoscopic; Pediatric; Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic; Transrectal and Transvaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (adult & pediatric); Peripheral Vascular. The subject-modified device is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB3; Abdominal (GYN & Urology); Intra-operative (abdominal, thoracic and PV); Laparoscopic; Pediatric; Small Organ (breast, testes, thyroid), Neonatal and Adult Cephalic; Transrectal and Transvaginal; Musculo-skeletal (Conventional and Superficial); Cardiac (adult & pediatric); Peripheral Vascular.

Source page: https://510kreport.com/device/K110482
Methodology: https://510kreport.com/methodology