# K140364: Chison Diagnostic Ultrasound System, Convex Probe, Linear Probe, Phased and Convex Probe, Pencil and Convex Probe

- Pathway: 510(k) (Traditional)
- Applicant: Chison Medical Imaging Co., Ltd.
- Decided: Jun 2, 2014 after 110 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: 6 generations back to K003525 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101236: Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/ H48681BX/ H48681BM, GE Healthcare (2011) Summary page 1.
- K120801: Chison Diagnostic Ultrasound System, Chison Medical Imaging Co., Ltd. (2012) Summary page 1.

## Indications for use
The device is a general-purpose ultrasonic imaging instument intended for use by a qualified physician for evaluation of Fetal/OB: Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid): Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transvaginal.

Source page: https://510kreport.com/device/K140364
Methodology: https://510kreport.com/methodology