Portable Digital Color Doppler Ultrasound System
FDA 510(k) K131088 · Sonoscape Company Limited
510(k) numberK131088
Submission
- Device name
- Portable Digital Color Doppler Ultrasound System
- Applicant
- Sonoscape Company Limited
Shenzhen, Guangdong, CN - Received
- April 18, 2013
- Decision date
- May 24, 2013
- 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 |
|---|---|---|
| K150045 | S30/S40 Digital Color Doppler Ultraound SystemIYN · Traditional | 04/28/2015SE |
| K142714 | S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound SystemIYN · Traditional | 01/29/2015SE |
| K142815 | S22 Digital Color Doppler Ultrasound SystemIYN · Traditional | 01/28/2015SE |
| K142710 | S9 Portable Digital Color Doppler Ultrasound SystemIYN · Traditional | 01/05/2015SE |
| K142474 | S12 Digital Color Doppler Ultrasound SystemIYN · Traditional | 12/19/2014SE |
| K132527 | Digital Color Doppler Ultasound SystemIYN · Traditional | 11/14/2013SE |
| K131262 | Digital ElectrocardiographsDPS · Traditional | 11/14/2013SE |
| K132768 | S8 Exp Portable Digital Color Doppler Ultrasound SystemIYN · Special | 10/04/2013SE |
| K131213 | Digital Color Doppler Ultrasound SystemIYN · Traditional | 06/21/2013SE |
| K130801 | Digital Color Doppler Ultrasound SystemIYN · Traditional | 06/14/2013SE |
Questions and answers
When was Portable Digital Color Doppler Ultrasound System cleared by the FDA?
Portable Digital Color Doppler Ultrasound System (K131088) received a 510(k) decision of Substantially Equivalent on May 24, 2013, 36 days after the submission was received.
What is the product code of K131088?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.