# K161439: E-CUBE 11

- Pathway: 510(k) (Traditional)
- Applicant: Alpinion Medical Systems Co., Ltd.
- Decided: Sep 21, 2016 after 120 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: 23 generations back to K924432 (1993). 259 ancestors in all.
12 later devices descend from it; 3 cite it directly.
6 of 272 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150773: E-CUBE 15 Diagnostic Ultrasound System, Alpinion Medical Systems Co., Ltd. (2015) Summary page 5.
- K153424: E-CUBE i7, Alpinion Medical Systems Co., Ltd. (2016) Summary page 18.
- K132687: E-CUBE 7, Alpinion Medical Systems Co., Ltd. (2013) Summary page 8.

## Most influential descendants
- 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
- K211300: X-CUBE 90 (2021), 3 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/K161439
Methodology: https://510kreport.com/methodology