Digital Color Doppler Ultrasound Imagaing System; Convex / Linear Phased Array Transducer
FDA 510(k) K103144 · Shantou Institute of Ultrasonic Instruments (Siui
510(k) numberK103144
Submission
- Device name
- Digital Color Doppler Ultrasound Imagaing System; Convex / Linear Phased Array Transducer
- Applicant
- Shantou Institute of Ultrasonic Instruments (Siui
Dublin, CA, US - Received
- October 25, 2010
- Decision date
- January 12, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IYN
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|---|---|---|---|
| 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 |
|---|---|---|
| K110841 | Digital Color Doppler Ultrasound Imaging System, Convex / Linear / Phased Array TransducerIYN · Special | 04/15/2011SE |
| K102023 | Digital Color Doppler Ultrasound Imaging System, Model Apogee 3500, Convex Array…IYN · Traditional | 10/19/2010SE |
| K101008 | Digital Color Doppler Ultrasound Imaging System, Convex Array Transducer, Linear ArrayITX · Traditional | 06/08/2010SE |
| K061488 | CTS-5500/CTS-6600 Ultrasonic Pulsed Echo Imaging SystemIYN · Special | 06/30/2006SE |
Questions and answers
When was Digital Color Doppler Ultrasound Imagaing System; Convex / Linear Phased Array Transducer cleared by the FDA?
Digital Color Doppler Ultrasound Imagaing System; Convex / Linear Phased Array Transducer (K103144) received a 510(k) decision of Substantially Equivalent on January 12, 2011, 79 days after the submission was received.
What is the product code of K103144?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.