# K101455: Eko 7 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Medison Co., Ltd.
- Decided: Jul 19, 2010 after 55 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: 12 generations back to K924432 (1993). 22 ancestors in all.
111 later devices descend from it; 3 cite it directly.
0 of 134 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092159: Accuvix V20 Diagnostic Ultrasound System, Medison Co., Ltd. (2009) Summary page 1.
- K093849: Accuvix V10 Diagnostic Ultrasound System, Medison Co., Ltd. (2010) Summary page 1.
- K020789: GE Vivid 3 Expert; GE Vivid 3 Pro, General Electric Co. (2002) Summary page 1.

## Most influential descendants
- K103397: Accuvix XG Diagnostic Ultrasound System (2011), 110 descendants of its own
- K112339: Accuvix A30 Diagnostic Ultrasound System (2011), 109 descendants of its own
- K122583: Ugeo G60 Diagnostic Ultrasound System (2012), 108 descendants of its own
- K130803: Ugeo H70C Diagnostic Ultrasound System (2013), 106 descendants of its own
- K133329: Ugeo WS80A Diagnostic Ultrasound System (2013), 102 descendants of its own

## Indications for use
The EKO 7 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-esophageal (non-Cardiac, Cardiac), Muscular-Skeletal (conventional, superficial), Cardiac Adult, Cardiac Peliatric and Peripheral-vessel.

Source page: https://510kreport.com/device/K101455
Methodology: https://510kreport.com/methodology