# K061827: Sonix Ultrasound Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Ultrasonix Medical Corporation
- Decided: Aug 4, 2006 after 37 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: 3 generations back to K935595 (1995). 4 ancestors in all.
586 later devices descend from it; 3 cite it directly.
0 of 591 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020630: Ultrasonix Ergosonix 500 Ultrasound Scanner, Ultrasonix Medical Corporation (2002) Summary page 2.
- K002003: Hdi 5000 Ultrasound System with Extended Field of View Imaging, Atl Ultrasound, Inc. (2000) Summary page 2.
- K973767: Harmonic Imaging with Contrast, Acuson Corp. (1997) Summary page 2.

## Most influential descendants
- K080935: Sonix MDP Ultrasound Scanner (2008), 584 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K061827
Methodology: https://510kreport.com/methodology