# K172732: E-CUBE 8

- Pathway: 510(k) (Traditional)
- Applicant: Alpinion Medical Systems Co., Ltd.
- Decided: Dec 14, 2017 after 94 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: 26 generations back to K924432 (1993). 327 ancestors in all.
11 later devices descend from it; 3 cite it directly.
6 of 339 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161439: E-CUBE 11, Alpinion Medical Systems Co., Ltd. (2016) Summary page 8.
- K153424: E-CUBE i7, Alpinion Medical Systems Co., Ltd. (2016) Summary page 6.
- K132687: E-CUBE 7, Alpinion Medical Systems Co., Ltd. (2013) Summary page 15.
- K163691: HS70A Diagnostic Ultrasound System, Samsung Medison Co., Ltd. (2017) Summary page 18.
- 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 18.

## Most influential descendants
- K181277: E-CUBE 12 (2018), 7 descendants of its own
- 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

## 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/K172732
Methodology: https://510kreport.com/methodology