# K170374: SonoBook Series Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Chison Medical Imaging Co., Ltd.
- Decided: Jun 6, 2017 after 119 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: 22 generations back to K935595 (1995). 198 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 204 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150861: QBit Series Diagnostic Ultrasound System, Chison Medical Imaging Co., Ltd. (2015) Summary page 33.

## Most influential descendants
- 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
- 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
- K173962: Viamo c100 TUS-VC100 Diagnostic Ultrasound System (2018), 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/K170374
Methodology: https://510kreport.com/methodology