Sonix MDP Ultrasound Scanner
FDA 510(k) K080935 · Ultrasonix Medical Corporation
510(k) numberK080935
Submission
- Device name
- Sonix MDP Ultrasound Scanner
- Applicant
- Ultrasonix Medical Corporation
Richmond, CA - Received
- April 2, 2008
- Decision date
- August 6, 2008
- 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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| K121812 | SonixgpsBSP · Traditional | 12/02/2013SE |
| K111818 | Sonixgps Needle SensorIYO · Traditional | 06/13/2012SE |
| K113663 | Sonixtablet Ultrasound ScannerIYN · Traditional | 01/25/2012SE |
| K112726 | Sonix Ultrasound ScannerIYN · Traditional | 09/27/2011SE |
| K102997 | Sonixtablet Ultrasound ScannerIYN · Traditional | 12/21/2010SE |
| K093462 | Sonix Ultrasound ScannerITX · Traditional | 11/20/2009SE |
| K083095 | Sonixtouch Ultrasound SystemIYN · Traditional | 10/31/2008SE |
| K061827 | Sonix Ultrasound ScannerIYN · Traditional | 08/04/2006SE |
| K042326 | Ergosonix Ultrasound Scanner, Modulo Ultrasound ScannerIYN · Traditional | 09/16/2004SE |
| K020630 | Ultrasonix Ergosonix 500 Ultrasound ScannerIYN · Traditional | 06/13/2002SE |
Questions and answers
When was Sonix MDP Ultrasound Scanner cleared by the FDA?
Sonix MDP Ultrasound Scanner (K080935) received a 510(k) decision of Substantially Equivalent on August 6, 2008, 126 days after the submission was received.
What is the product code of K080935?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.