# K083095: Sonixtouch Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Ultrasonix Medical Corporation
- Decided: Oct 31, 2008 after 14 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: 11 generations back to K935595 (1995). 87 ancestors in all.
582 later devices descend from it; 6 cite it directly.
0 of 670 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080935: Sonix MDP Ultrasound Scanner, Ultrasonix Medical Corporation (2008) Summary page 2.
- K061827: Sonix Ultrasound Scanner, Ultrasonix Medical Corporation (2006) Summary page 2.
- K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series), Sonosite,Inc. (2005) Summary page 2.
- K062247: HD11 Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2006) Summary page 2.
- K060993: GE Logiq P5 and A5, General Electric Co. (2006) Summary page 2.
- K080223: Zura Tee System, Imacor, LLC (2008) Summary page 2.
- K072786: Acuson S2000 Ultrasound System, Siemens Medical Solutions USA, Inc. (2007) Summary page 2.
- K061215: Volcano S51 Family of Imaging Systems, Volcano Corporation (2006) Summary page 2.

## Most influential descendants
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own
- K110943: Logiq E9 (2011), 472 descendants of its own
- K113690: GE Logiq I, Logiq E and Vivid E (2011), 469 descendants of its own
- K111582: Logiq S8 (2011), 367 descendants of its own
- K122327: Voluson E6/E8/E8EXPERT/E10 (2012), 365 descendants of its own

## Indications for use
The SonixTouch Ultrasound Scanner is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal/ Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve Block, Vascular Access, Transcranial. The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal} and provides calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Source page: https://510kreport.com/device/K083095
Methodology: https://510kreport.com/methodology