# K180974: CBit Series Digital Color Doppler Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: CHISON Medical Technologies Co., Ltd.
- Decided: Aug 17, 2018 after 126 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.
3 later devices descend from it; 1 cites it directly.
0 of 203 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170374: SonoBook Series Diagnostic Ultrasound System, Chison Medical Imaging Co., Ltd. (2017) Summary page 35.
- (no number) CHISON SonoBook 9 Diagnostic Ultrasound System: named in the summary without a submission number

## Most influential descendants
- K200780: XBit Series Digital Color Doppler Ultrasound System (2020), 2 descendants of its own
- K233697: SonoMax Series Digital Color Doppler Ultrasound System (2024), 1 descendant of its own
- K253949: SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 (2026), 0 descendants of its own

## Indications for use
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Neonatal Cephalic ,Adult Cephalic, Cardiac (adult , pediatric), Musculo -skeletal (Conventional, Superficial),Peripheral Vascular, Trans-esophageal, Trans-rectal,Trans-vaginal, OB/GYN and Urology.

Source page: https://510kreport.com/device/K180974
Methodology: https://510kreport.com/methodology