# K120801: Chison Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Chison Medical Imaging Co., Ltd.
- Decided: Jun 14, 2012 after 90 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: 5 generations back to K003525 (2000). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.

## Most influential descendants
- K140364: Chison Diagnostic Ultrasound System, Convex Probe, Linear Probe, Phased and Convex Probe, Pencil and Convex Probe (2014), 0 descendants of its own

## Indications for use
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal (Obstetrics),Abdomen, Cardiac(Adult, Pediatric), Small Organ (Thyroid, testes and breast etc), Peripheral Vascular, Transvaginal, Musculo-skeletal (Conventional and Superficial), Pediatric, OB/Gyn and Urology.

Source page: https://510kreport.com/device/K120801
Methodology: https://510kreport.com/methodology