# K120060: E-CUBE 9

- Pathway: 510(k) (Traditional)
- Applicant: Alpinion Medical Systems Co., Ltd.
- Decided: Mar 16, 2012 after 67 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: 4 generations back to K010329 (2001). 4 ancestors in all.
23 later devices descend from it; 6 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060993: GE Logiq P5 and A5, General Electric Co. (2006) Summary page 1.

## Most influential descendants
- K132687: E-CUBE 7 (2013), 16 descendants of its own
- K150773: E-CUBE 15 Diagnostic Ultrasound System (2015), 15 descendants of its own
- K142733: E-CUBE 5 (2014), 15 descendants of its own
- K153424: E-CUBE i7 (2016), 14 descendants of its own
- K161439: E-CUBE 11 (2016), 12 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(TR); Trans-vaginal(TV); Musculo-skeletal(ConventiOflal); Musculo-skeletal (Superficial): Cardiac (adult & pediatric); Peripheral Vascular (PV); and Urology (including prostate).

Source page: https://510kreport.com/device/K120060
Methodology: https://510kreport.com/methodology