Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)
FDA 510(k) K232908 · Contec Medical Systems Co.,Ltd
510(k) numberK232908
Submission
- Device name
- Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C)
- Applicant
- Contec Medical Systems Co.,Ltd
Qinghuangdao, CN - Received
- September 19, 2023
- Decision date
- May 2, 2024
- 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 |
|---|---|---|
| K232893 | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal…KNG · Traditional | 06/14/2024SE |
| K232895 | B-Ultrasound Diagnostic SystemIYO · Traditional | 05/03/2024SE |
| K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)KNG · Traditional | 09/28/2022SE |
| K202757 | CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50…DXN · Traditional | 04/28/2021SE |
| K201980 | Infrared ThermometerFLL · Traditional | 12/18/2020SE |
| K171360 | CONTEC ElectrocardiographDPS · Traditional | 01/22/2018SE |
| K170856 | CMS600P2 B-Ultrasound Diagnostic SystemIYO · Traditional | 11/17/2017SE |
| K170954 | Portable ECG MonitorDPS · Traditional | 05/30/2017SE |
| K152863 | Portable ECG MonitorDPS · Traditional | 06/22/2016SE |
| K141362 | Pulse Oximeter CMS50EWDQA · Traditional | 04/23/2015SE |
Questions and answers
When was Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) cleared by the FDA?
Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) (K232908) received a 510(k) decision of Substantially Equivalent on May 2, 2024, 226 days after the submission was received.
What is the product code of K232908?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.