# K150773: E-CUBE 15 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Alpinion Medical Systems Co., Ltd.
- Decided: Jul 23, 2015 after 121 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: 16 generations back to K935595 (1995). 130 ancestors in all.
15 later devices descend from it; 4 cite it directly.
6 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120060: E-CUBE 9, Alpinion Medical Systems Co., Ltd. (2012) Summary page 31.
- K132304: Epiq Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2013) Summary page 36.

## 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): Adult Cephalic; Trans-rectal, Trans-vaginal. Musculo-skeletal(Conventional); Musculo-skeletal (Superticial); Cardiac (adult& pediatric): Peripheral Vascular (PV): and Urology (including prostate).

Source page: https://510kreport.com/device/K150773
Methodology: https://510kreport.com/methodology