# K182845: minisono

- Pathway: 510(k) (Traditional)
- Applicant: Alpinion Medical Systems Co., Ltd.
- Decided: Dec 27, 2018 after 79 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: 23 generations back to K924432 (1993). 259 ancestors in all.
No later device cites it as a predicate yet.
6 of 260 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153424: E-CUBE i7, Alpinion Medical Systems Co., Ltd. (2016) Summary page 6.

## 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; Pediatric, Small Organ (breast, testes, thyroid); Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Peripheral Vascular (PV); and Urology (including prostate).

Source page: https://510kreport.com/device/K182845
Methodology: https://510kreport.com/methodology