# K181277: E-CUBE 12

- Pathway: 510(k) (Traditional)
- Applicant: Alpinion Medical Systems Co., Ltd.
- Decided: Sep 28, 2018 after 137 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). 337 ancestors in all.
7 later devices descend from it; 2 cite it directly.
6 of 345 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172732: E-CUBE 8, Alpinion Medical Systems Co., Ltd. (2017) Summary page 4.
- K161439: E-CUBE 11, Alpinion Medical Systems Co., Ltd. (2016) Summary page 4.
- K150773: E-CUBE 15 Diagnostic Ultrasound System, Alpinion Medical Systems Co., Ltd. (2015) Summary page 4.
- K173713: HS70A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- 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
- K211299: X-CUBE 70 (2021), 3 descendants of its own
- K220857: X-Cube 50, X-Cube 60 (2022), 1 descendant 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), Neonatal Cephalic, 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/K181277
Methodology: https://510kreport.com/methodology