# K182594: E-CUBE i7

- Pathway: 510(k) (Traditional)
- Applicant: Alpinion Medical Systems Co., Ltd.
- Decided: Jan 24, 2019 after 126 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: 27 generations back to K924432 (1993). 328 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 330 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153424: E-CUBE i7, Alpinion Medical Systems Co., Ltd. (2016) Summary page 5.
- K150773: E-CUBE 15 Diagnostic Ultrasound System, Alpinion Medical Systems Co., Ltd. (2015) Summary page 20.
- K172732: E-CUBE 8, Alpinion Medical Systems Co., Ltd. (2017) Summary page 13.
- K132687: E-CUBE 7, Alpinion Medical Systems Co., Ltd. (2013) Summary page 17.

## Most influential descendants
- K213523: X-CUBE i8, X-CUBE i9 (2022), 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); Adult Cephalic; 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/K182594
Methodology: https://510kreport.com/methodology