# K181617: E-CUBE 8

- Pathway: 510(k) (Traditional)
- Applicant: Alpinion Medical Systems Co., Ltd.
- Decided: Oct 11, 2018 after 114 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.
No later device cites it as a predicate yet.
6 of 329 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 18.
- K153424: E-CUBE i7, Alpinion Medical Systems Co., Ltd. (2016) Summary page 23.
- K132687: E-CUBE 7, Alpinion Medical Systems Co., Ltd. (2013) Summary page 24.
- K163691: HS70A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2017) Summary page 24.
- K163120: EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2017) Summary page 24.

## 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/K181617
Methodology: https://510kreport.com/methodology