# K162172: EBit Series Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Chison Medical Imaging Co., Ltd.
- Decided: Sep 14, 2016 after 42 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 K935595 (1995). 199 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 201 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153085: Q Series Diagnostic Ultrasound System, Chison Medical Imaging Co., Ltd. (2015) Summary page 35.
- K150861: QBit Series Diagnostic Ultrasound System, Chison Medical Imaging Co., Ltd. (2015) Summary page 36.

## Most influential descendants
- K223570: SonoAir Series Digital Color Doppler Ultrasound System (2023), 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 ,Abdominal,Pediatric,Small Organ (breast, thyroid,testes ), Neonatal Cephalic ,Adult Cephalic,Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Transesophageal,Transrectal, Transvaginal, Urology.

Source page: https://510kreport.com/device/K162172
Methodology: https://510kreport.com/methodology