SonoBook Series Diagnostic Ultrasound System
FDA 510(k) K170374 · Chison Medical Imaging Co., Ltd.
510(k) numberK170374
Submission
- Device name
- SonoBook Series Diagnostic Ultrasound System
- Applicant
- Chison Medical Imaging Co., Ltd.
Wuxi, CN - Received
- February 7, 2017
- Decision date
- June 6, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IYN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261313 | Vivid Explorer/Vivid Advanced/Vivid FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 09/02/2026SE |
| K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…IYN · Traditional | Sonoscape Medical Corp. | 08/24/2026SE |
| K261668 | Venue GoIYN · Traditional | GE Medical Systems Ultrasound and Primary care… | 08/07/2026SE |
| K262311 | Alturion Series Diagnostic Ultrasound SystemIYN · Special | Philips Ultrasound, LLC | 08/04/2026SE |
| K261835 | LOGIQ FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 07/30/2026SE |
| K261288 | Handheld Ultrasound ScannerIYN · Traditional | Imgfax Co., Ltd. | 07/30/2026SE |
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…IYN · Traditional | Samsung Medison Co., Ltd. | 07/28/2026SE |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…IYN · Traditional | Philips Ultrasound, LLC | 07/27/2026SE |
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…IYN · Traditional | Esonic Technology (Wuhan) Co., Ltd. | 07/23/2026SE |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)IYN · Special | Beijing Konted Medical Technology Co.,Ltd | 07/23/2026SE |
More from Beijing Konted Medical Technology Co.,Ltd
| 510(k) | Device | Decision |
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| K170870 | Site~Rite Halcyon Diagnostic Ultrasound SystemIYN · Traditional | 07/06/2017SE |
| K162172 | EBit Series Diagnostic Ultrasound SystemIYN · Traditional | 09/14/2016SE |
| K153085 | Q Series Diagnostic Ultrasound SystemIYN · Traditional | 12/21/2015SE |
| K150861 | QBit Series Diagnostic Ultrasound SystemIYN · Traditional | 07/28/2015SE |
| K140364 | Chison Diagnostic Ultrasound System, Convex Probe, Linear Probe, Phased and Convex…IYN · Traditional | 06/02/2014SE |
| K131305 | Chison Diagnostic Ultrasound System, Convex Probe, Lincar Probe, Phased ProbeIYN · Traditional | 08/01/2013SE |
| K121867 | Sonotouch Series Diagnostic Ultrasound SystemsIYN · Traditional | 08/02/2012SE |
| K120801 | Chison Diagnostic Ultrasound SystemIYN · Traditional | 06/14/2012SE |
| K113359 | Chison Diagnostic Ultrasound System,Convex Probe,Linear Probe,Transvaginal Micro-Convex…IYN · Traditional | 02/03/2012SE |
| K091877 | Chison Digital Color Doppler Ultrasound System, Convex Probe, Linear Probe, Phased Array…ITX · Traditional | 09/02/2009SE |
Questions and answers
When was SonoBook Series Diagnostic Ultrasound System cleared by the FDA?
SonoBook Series Diagnostic Ultrasound System (K170374) received a 510(k) decision of Substantially Equivalent on June 6, 2017, 119 days after the submission was received.
What is the product code of K170374?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.