# K121937: E-Cube Inno

- Pathway: 510(k) (Traditional)
- Applicant: Alpinion Medical Systems Co., Ltd.
- Decided: Jul 26, 2012 after 24 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: 15 generations back to K935595 (1995). 108 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113690: GE Logiq I, Logiq E and Vivid E, GE Healthcare (2011) Summary page 1.

## Most influential descendants
- K153424: E-CUBE i7 (2016), 14 descendants of its own
- 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

## 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); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV) and Urology (including prostate).

Source page: https://510kreport.com/device/K121937
Methodology: https://510kreport.com/methodology