# K112726: Sonix Ultrasound Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Ultrasonix Medical Corporation
- Decided: Sep 27, 2011 after 7 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: 13 generations back to K935595 (1995). 107 ancestors in all.
No later device cites it as a predicate yet.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093462: Sonix Ultrasound Scanner, Ultrasonix Medical Corporation (2009) Summary page 2.

## Indications for use
The Sonix 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 dataobtained by a physician for clinical diagnosis purposes.

Source page: https://510kreport.com/device/K112726
Methodology: https://510kreport.com/methodology