# K213523: X-CUBE i8, X-CUBE i9

- Pathway: 510(k) (Traditional)
- Applicant: Alpinion Medical Systems Co., Ltd.
- Decided: Jan 28, 2022 after 86 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: 28 generations back to K924432 (1993). 329 ancestors in all.
No later device cites it as a predicate yet.
6 of 330 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182594: E-CUBE i7, Alpinion Medical Systems Co., Ltd. (2019) Summary page 4.

## Indications for use
The X-CUBE i8, X-CUBE 19 diagnostic ultrasound systems are intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of 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); Trans-esoph. (Cardiac); Peripheral Vessel(PV); and Urology(including prostate). And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode. The X-CUBE 18, X-CUBE 19 are intended to be used in a hospital or medical clinic.

Source page: https://510kreport.com/device/K213523
Methodology: https://510kreport.com/methodology