# K150861: QBit Series Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Chison Medical Imaging Co., Ltd.
- Decided: Jul 28, 2015 after 118 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: 21 generations back to K935595 (1995). 197 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 207 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132341: DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound Systems, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2013) Summary page 32.

## Most influential descendants
- K170374: SonoBook Series Diagnostic Ultrasound System (2017), 5 descendants of its own
- K180974: CBit Series Digital Color Doppler Ultrasound System (2018), 3 descendants of its own
- K200780: XBit Series Digital Color Doppler Ultrasound System (2020), 2 descendants of its own
- K153085: Q Series Diagnostic Ultrasound System (2015), 2 descendants of its own
- K233697: SonoMax Series Digital Color Doppler Ultrasound System (2024), 1 descendant 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/K150861
Methodology: https://510kreport.com/methodology