# K123610: E-CUBE 15

- Pathway: 510(k) (Traditional)
- Applicant: Alpinion Medical Systems Co., Ltd.
- Decided: Feb 1, 2013 after 72 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: 5 generations back to K010329 (2001). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 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 1.

## Most influential descendants
- K142884: E-CUBE 12 (2014), 0 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); Trans-rectal, Trans-vaginal, Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV); and Urology (including prostate).

Source page: https://510kreport.com/device/K123610
Methodology: https://510kreport.com/methodology