# K042326: Ergosonix Ultrasound Scanner, Modulo Ultrasound Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Ultrasonix Medical Corporation
- Decided: Sep 16, 2004 after 20 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.
590 later devices descend from it; 5 cite it directly.
0 of 595 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
- K080223: Zura Tee System (2008), 583 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

## Indications for use
The Ergosonix and Modulo Ultrasound Scanners are intended for use in obstetrics/gynecology, general radiology, cardiac examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. The specific intended uses of this system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), cephalic, small organ (breast, thyroid, testicle), trans-vaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric), transcranial, transesophageal.

Source page: https://510kreport.com/device/K042326
Methodology: https://510kreport.com/methodology