# K113359: Chison Diagnostic Ultrasound System,Convex Probe,Linear Probe,Transvaginal Micro-Convex Probe

- Pathway: 510(k) (Traditional)
- Applicant: Chison Medical Imaging Co., Ltd.
- Decided: Feb 3, 2012 after 81 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.
No later device cites it as a predicate yet.
0 of 6 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.

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

Source page: https://510kreport.com/device/K113359
Methodology: https://510kreport.com/methodology