# K153424: E-CUBE i7

- Pathway: 510(k) (Traditional)
- Applicant: Alpinion Medical Systems Co., Ltd.
- Decided: Feb 26, 2016 after 93 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: 22 generations back to K924432 (1993). 258 ancestors in all.
14 later devices descend from it; 5 cite it directly.
6 of 273 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121937: E-Cube Inno, Alpinion Medical Systems Co., Ltd. (2012) Summary page 13.
- K150773: E-CUBE 15 Diagnostic Ultrasound System, Alpinion Medical Systems Co., Ltd. (2015) Summary page 13.
- K151663: RS80A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2015) Summary page 13.
- K142733: E-CUBE 5, Alpinion Medical Systems Co., Ltd. (2014) Summary page 5.

## Most influential descendants
- K161439: E-CUBE 11 (2016), 12 descendants of its own
- K172732: E-CUBE 8 (2017), 11 descendants of its own
- K181277: E-CUBE 12 (2018), 7 descendants of its own
- K200449: X-Cube 90 (2020), 4 descendants of its own
- K200450: X-Cube 70 (2020), 4 descendants of its own

## Indications for use
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal (TR); Trans-vaginal (TV); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Peripheral Vascular (PV); and Urology (including prostate).

Source page: https://510kreport.com/device/K153424
Methodology: https://510kreport.com/methodology